Decrypting pharma.

This industry runs on abbreviations and four-character document codes, and almost nobody holds all of them at once. Every ICH guideline, the parts of 21 CFR that actually come up, the EU GMP annexes, the USP chapters, the PDA technical reports and nearly seven hundred acronyms, one thousand and six entries in one box. Type any of it, or any part of what it means, and it resolves.

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The ICH quality shelf, in the order it is actually used.

The Q series is not a list, it is a working set. These are the four groups it falls into once you are running a program, rather than the numeric order the guidelines were published in. Every code is a link into the reference above.

ICH · 70

Q1A(R2)
Stability Testing of New Drug Substances and Products
The core stability guideline: storage conditions, batch selection, testing frequency, and how long-term plus accelerated data support a retest period or shelf life.
Q1B
Photostability Testing of New Drug Substances and Products
Forced degradation and confirmatory photostability, including the option 1 and option 2 light sources.
Q1C
Stability Testing for New Dosage Forms
How much of a full stability package a new dosage form of an already approved substance needs.
Q1D
Bracketing and Matrixing Designs for Stability Testing
Reduced designs: when you may test only the extremes of a factor, or only a subset of time points.
Q1E
Evaluation of Stability Data
The statistical treatment: poolability testing, regression, and extrapolation beyond the observed data.
Q1F
Stability Data Package for Registration in Climatic Zones III and IV
Withdrawn in 2006. Zone IVb conditions reverted to regional definition, which is why 30 C / 75 percent RH is a regional expectation rather than an ICH one.
Q2(R2)
Validation of Analytical Procedures
Accuracy, precision, specificity, detection and quantitation limits, linearity, range. The 2023 revision widened it beyond the classic chromatographic assay to multivariate and other modern procedures.
Q3A(R2)
Impurities in New Drug Substances
Reporting, identification and qualification thresholds for organic impurities in the substance.
Q3B(R2)
Impurities in New Drug Products
The same threshold logic applied to degradation products in the finished product.
Q3C(R9)
Impurities: Guideline for Residual Solvents
Class 1, 2 and 3 solvents, permitted daily exposures, and the concentration limit versus PDE options.
Q3D(R2)
Guideline for Elemental Impurities
PDEs for elemental impurities by route, and the risk assessment that decides which elements you actually have to control.
Q3E
Extractables and Leachables
In development. Intended to harmonize E&L assessment for drug products and their container closure and manufacturing systems.
Q4B
Evaluation and Recommendation of Pharmacopoeial Texts
The mechanism by which a pharmacopoeial general chapter is declared interchangeable across the three regions, published as annexes.
Q5A(R2)
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Testing, clearance evaluation and the three-pronged viral safety approach. The 2023 revision brought in new modalities including gene therapy vectors.
Q5B
Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Genetic characterization of the construct and its stability over the production process.
Q5C
Stability Testing of Biotechnological/Biological Products
How stability differs for proteins: the reliance on a battery of methods rather than a single stability-indicating assay.
Q5D
Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
Cell banking: the two-tiered master and working cell bank system, and what characterization each needs.
Q5E
Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
The comparability exercise for your own product after a process change. Distinct from biosimilarity, which compares two different manufacturers' products.
Q6A
Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
What goes on a specification for a small molecule, including the decision trees for polymorphs, particle size and dissolution.
Q6B
Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
The equivalent for proteins: identity, purity, potency, quantity, and why potency needs a biological assay.
Q7
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
GMP for the drug substance, including where in the synthesis GMP starts to apply.
Q8(R2)
Pharmaceutical Development
The QbD guideline. QTPP, critical quality attributes, design space, control strategy, and the distinction between a minimal and an enhanced approach.
Q9(R1)
Quality Risk Management
The risk framework the rest of the system leans on. The 2023 revision addressed subjectivity, formality of risk management, and risk-based decision making.
Q10
Pharmaceutical Quality System
The PQS across the lifecycle: management responsibility, CAPA, change management, and management review. Built on ISO 9001 concepts plus GMP.
Q11
Development and Manufacture of Drug Substances
Q8 thinking applied to the drug substance, including starting material selection, which is one of the most frequently challenged parts of a filing.
Q12
Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Established Conditions, the PACMP, and the Product Lifecycle Management document. The tool that decides how much of your process is legally locked.
Q13
Continuous Manufacturing of Drug Substances and Drug Products
Control strategy for CM, including residence time distribution, material diversion, and what a batch means when the process does not stop.
Q14
Analytical Procedure Development
The analytical twin of Q8: analytical target profile, method risk assessment, and the enhanced approach to method development. Published alongside Q2(R2).
S1A / S1B(R1) / S1C(R2)
Carcinogenicity Studies
When carcinogenicity testing is needed, the testing scheme, and dose selection. S1B(R1) added the weight-of-evidence route to waive the two-year rat study.
S2(R1)
Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
The standard battery and how to follow up a positive result.
S3A / S3B
Toxicokinetics and Pharmacokinetics
Exposure assessment within toxicity studies, and repeated dose tissue distribution.
S4
Duration of Chronic Toxicity Testing in Animals
Six months in rodents, nine months in non-rodents.
S5(R3)
Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals
The reproductive toxicology package, including alternative assays and exposure-based approaches.
S6(R1)
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Why the standard small molecule tox package does not fit a monoclonal antibody: species relevance, immunogenicity, and the homologous protein option.
S7A / S7B
Safety Pharmacology Studies
Core battery for cardiovascular, respiratory and CNS. S7B covers delayed ventricular repolarization, the nonclinical partner to E14.
S8
Immunotoxicity Studies for Human Pharmaceuticals
When a cause for concern triggers additional immunotoxicity work.
S9
Nonclinical Evaluation for Anticancer Pharmaceuticals
A reduced, faster package justified by the seriousness of the indication.
S10
Photosafety Evaluation of Pharmaceuticals
When a molecule's absorption spectrum obliges you to assess phototoxicity.
S11
Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals
Juvenile animal studies: when they add information and when they do not.
S12
Nonclinical Biodistribution Considerations for Gene Therapy Products
Where the vector goes, how long it persists, and what that means for the study design.
E1
The Extent of Population Exposure to Assess Clinical Safety
The 1500 / 300 / 100 patient exposure expectations for long-term treatment of non-life-threatening conditions.
E2A-E2F
Pharmacovigilance
Expedited reporting definitions (E2A), data elements (E2B), PSUR and PBRER (E2C), post-approval safety data (E2D), risk management planning (E2E), and DSUR (E2F).
E3
Structure and Content of Clinical Study Reports
The CSR template, and what belongs in the appendices.
E4
Dose-Response Information to Support Drug Registration
Why a dose-response relationship, not just a single effective dose, is what a submission needs.
E5(R1)
Ethnic Factors in the Acceptability of Foreign Clinical Data
The bridging study concept, and intrinsic versus extrinsic ethnic factors.
E6(R2) / E6(R3)
Good Clinical Practice
The GCP standard. R2 added quality by design, risk-based monitoring and the essential-records expectations; R3 restructured the guideline around principles and modern trial designs.
E7
Studies in Support of Special Populations: Geriatrics
Representation of older patients, and the interactions and comorbidities that come with them.
E8(R1)
General Considerations for Clinical Studies
The umbrella guideline. R1 introduced quality by design for clinical studies and the idea of critical to quality factors.
E9(R1)
Statistical Principles for Clinical Trials, with the Estimand Addendum
The R1 addendum introduced the estimand framework, which forces you to state precisely what treatment effect you are estimating before you choose an analysis.
E10
Choice of Control Group and Related Issues in Clinical Trials
Placebo, active control, non-inferiority, and assay sensitivity.
E11(R1) / E11A
Clinical Investigation of Medicinal Products in the Paediatric Population
Paediatric development, with E11A covering paediatric extrapolation from adult or other data.
E14
Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
The thorough QT study and its alternatives, now read together with S7B and concentration-QTc modeling.
E15
Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
The shared vocabulary the other genomics guidelines depend on.
E16
Biomarkers Related to Drug or Biotechnology Product Development
Qualification of a biomarker: context of use, and the evidence needed for it.
E17
General Principles for Planning and Design of Multi-Regional Clinical Trials
How to design one trial that supports registration in several regions at once.
E18
Genomic Sampling and Management of Genomic Data
Collecting and handling genomic samples in clinical studies.
E19
Optimization of Safety Data Collection
When selective safety data collection is scientifically justified in later-phase trials.
E20
Adaptive Designs for Clinical Trials
In development. Intended to harmonize expectations for pre-planned adaptations.
M1
MedDRA: Medical Dictionary for Regulatory Activities
The terminology used to code adverse events and medical history across regions.
M2
Electronic Standards for the Transfer of Regulatory Information
The technical standards underneath electronic submission and safety reporting.
M3(R2)
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
What nonclinical work must be finished before each stage of clinical development. The guideline that sets the pace of a program.
M4 (M4Q / M4S / M4E)
The Common Technical Document
The CTD structure: Module 1 regional, 2 summaries, 3 quality, 4 nonclinical, 5 clinical. M4Q is Module 3, where CMC lives.
M7(R2)
Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
The mutagenic impurity guideline: the classification scheme, the TTC, and the (Q)SAR pair. The framework nitrosamine work is built on.
M8
Electronic Common Technical Document
The eCTD specification, the format an application is actually submitted in.
M9
Biopharmaceutics Classification System-Based Biowaivers
When dissolution data can replace a bioequivalence study for BCS class I and III products.
M10
Bioanalytical Method Validation and Study Sample Analysis
Validation of the assays that generate PK and toxicokinetic data, for both chromatographic and ligand binding assays.
M11
Clinical Electronic Structured Harmonized Protocol
A common template and technical specification for clinical trial protocols.
M12
Drug Interaction Studies
Harmonized design and interpretation of in vitro and clinical drug-drug interaction studies.
M13A
Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Harmonized bioequivalence study design for immediate-release oral products.
M14
General Principles on Planning and Designing Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment
Use of real-world data in safety assessment.

21 CFR · 65

21 CFR 11
Electronic Records; Electronic Signatures
When an electronic record is trustworthy enough to stand in for paper: audit trails, system validation, access control, and signature manifestations. The rule every LIMS, MES and eBR validation is written against.
21 CFR 50
Protection of Human Subjects
Informed consent requirements for clinical investigations.
21 CFR 54
Financial Disclosure by Clinical Investigators
Disclosure of investigator financial interests that could bias a study.
21 CFR 56
Institutional Review Boards
Composition, function and record keeping for IRBs.
21 CFR 58
Good Laboratory Practice for Nonclinical Laboratory Studies
GLP. Applies to safety studies, not to the QC laboratory, which is a distinction that catches people out.
21 CFR 201
Labeling
Prescription drug labeling content and format, including the Highlights section.
21 CFR 202
Prescription Drug Advertising
What promotional material may claim and how risk must be presented.
21 CFR 203
Prescription Drug Marketing
Sample distribution, and the records that go with it.
21 CFR 205
Guidelines for State Licensing of Wholesale Prescription Drug Distributors
The distribution licensing framework.
21 CFR 206
Imprinting of Solid Oral Dosage Form Drug Products
Why tablets carry a code.
21 CFR 207
Requirements for Foreign and Domestic Establishment Registration and Listing
Registration and drug listing, and the NDC.
21 CFR 210
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
The short part: scope, applicability, and definitions. Part 211 is where the substance is.
21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals
US GMP for finished products. Subparts run from organization and personnel through buildings, equipment, components, production, packaging, holding, laboratory controls, records and returned goods.
21 CFR 211.22
Responsibilities of Quality Control Unit
The QCU's authority to approve or reject, and the requirement that its responsibilities be in writing.
21 CFR 211.68
Automatic, Mechanical, and Electronic Equipment
The computerized systems clause inside GMP: validation, and backup of records.
21 CFR 211.84
Testing and Approval or Rejection of Components, Drug Product Containers, and Closures
Sampling and identity testing of incoming materials.
21 CFR 211.100
Written Procedures; Deviations
Production and process control procedures must be written, followed, and deviations recorded and justified.
21 CFR 211.110
Sampling and Testing of In-Process Materials and Drug Products
In-process controls and the requirement to establish them.
21 CFR 211.113
Control of Microbiological Contamination
Including the requirement to validate sterilization processes.
21 CFR 211.160
General Requirements (Laboratory Controls)
Scientific soundness of specifications, standards and sampling plans.
21 CFR 211.165
Testing and Release for Distribution
Release testing, and the requirement for a stability-indicating method.
21 CFR 211.166
Stability Testing
The written stability program, and expiration dating.
21 CFR 211.180
General Requirements (Records and Reports)
Retention periods, and the annual product review.
21 CFR 211.188
Batch Production and Control Records
What a batch record must contain and capture.
21 CFR 211.192
Production Record Review
The out-of-specification clause: any unexplained discrepancy or failure of a batch to meet specification shall be thoroughly investigated, whether or not the batch has already been distributed.
21 CFR 211.194
Laboratory Records
Complete data derived from all tests, including raw data. The data integrity anchor in US GMP.
21 CFR 212
Current Good Manufacturing Practice for Positron Emission Tomography Drugs
A separate, shorter GMP for PET products, because their half-lives make normal release testing impossible.
21 CFR 314
Applications for FDA Approval to Market a New Drug
NDA and ANDA content and procedures.
21 CFR 314.70
Supplements and Other Changes to an Approved NDA
The post-approval change categories: prior approval supplement, changes being effected in 30 days, CBE-0, and annual report.
21 CFR 314.80 / 314.81
Postmarketing Reporting of Adverse Drug Experiences; Other Postmarketing Reports
Adverse event reporting, field alerts and the annual report.
21 CFR 314.94
Content and Format of an ANDA
What a generic application must contain.
21 CFR 316
Orphan Drugs
Designation, and the exclusivity that follows.
21 CFR 320
Bioavailability and Bioequivalence Requirements
Study requirements and in vivo waivers.
21 CFR 600
Biological Products: General
Definitions, establishment standards, and reporting for biologics.
21 CFR 601
Licensing
BLA procedures, including 601.12, which is the biologics equivalent of 314.70 for post-approval change.
21 CFR 601.12
Changes to an Approved Application
The four reporting categories for a licensed biologic, and the comparability protocol provision.
21 CFR 610
General Biological Products Standards
Potency, sterility, purity, identity and the general safety test.
21 CFR 820
Quality System Regulation / Quality Management System Regulation
Device GMP. Being harmonized with ISO 13485 as the QMSR, which folds the ISO standard in by reference.
21 CFR 4
Regulation of Combination Products
Which set of GMP rules applies when a product is a drug and a device at once, and the streamlined options.
21 CFR 1271
Human Cells, Tissues, and Cellular and Tissue-Based Products
HCT/P registration, donor eligibility and current good tissue practice.
21 CFR 312
Investigational New Drug Application
The IND itself: content and format, safety reporting, protocol amendments, charging for an investigational drug, and the thirty-day clock. The regulation the whole preclinical to clinical handover is written against.
21 CFR 312.23
IND Content and Format
What goes in the application, including the chemistry, manufacturing and control section and the environmental assessment.
21 CFR 312.32
IND Safety Reporting
Serious and unexpected suspected adverse reactions, and the seven and fifteen day clocks.
21 CFR 314.50
NDA Content and Format
The content of a new drug application, including the chemistry, manufacturing and control sections and the samples and labelling required.
21 CFR 211.25
Personnel Qualifications
Training in the operations performed and in current good manufacturing practice, with a record of it.
21 CFR 211.42
Design and Construction Features
The layout argument: flow of materials and people, and defined areas for operations that should not meet.
21 CFR 211.46
Ventilation, Air Filtration, Air Heating and Cooling
The regulation behind HVAC qualification, differential pressure and dust containment.
21 CFR 211.67
Equipment Cleaning and Maintenance
Cleaning at intervals that prevent malfunction and contamination, and the written procedures and records behind it.
21 CFR 211.72
Filters
Fibre releasing filters, and the requirement that drove non-fibre-releasing filtration.
21 CFR 211.94
Drug Product Containers and Closures
Containers that are not reactive, additive or absorptive, and the testing that shows it.
21 CFR 211.101
Charge-In of Components
Weighing and measuring, and the second check that prevents the wrong component going in.
21 CFR 211.111
Time Limitations on Production
Holding times between steps, established when appropriate to the process.
21 CFR 211.137
Expiration Dating
Expiration dates supported by stability data, and their relationship to the storage statement.
21 CFR 211.142
Warehousing Procedures
Quarantine, storage conditions and the control of stock before release.
21 CFR 211.170
Reserve Samples
How much to keep, how long, and the annual visual examination of them.
21 CFR 211.196
Distribution Records
Records that allow a lot to be traced and, if it comes to it, recalled.
21 CFR 211.198
Complaint Files
Written procedures for handling complaints, and the requirement to decide whether one is a reportable event.
21 CFR 600.14
Biological Product Deviation Reporting
The 45-day report for a deviation in a distributed licensed biological product.
21 CFR 610.12
Sterility
The compendial sterility requirement for licensed biologics, and the route to an alternative method.
21 CFR 606
Current Good Manufacturing Practice for Blood and Blood Components
Collection, processing, compatibility testing, storage and distribution of blood and blood components.
21 CFR 803
Medical Device Reporting
Adverse event reporting for devices, which a combination product inherits in part.
21 CFR 806
Medical Device Corrections and Removals
Reports of corrections and removals undertaken to reduce a risk to health, and the ones you may simply record instead.
21 CFR 807
Establishment Registration and Device Listing, and Premarket Notification
Where the 510(k) lives.
21 CFR 814
Premarket Approval of Medical Devices
The premarket approval route for class III devices, including manufacturing information and the PMA supplement.
21 CFR 25
Environmental Impact Considerations
Categorical exclusions and when an environmental assessment is actually required.

EU GMP & law · 32

EudraLex Volume 4
EU Guidelines for Good Manufacturing Practice
The EU GMP guide: Part I for medicinal products, Part II for active substances, Part III supporting documents, plus the annexes.
Annex 1
Manufacture of Sterile Medicinal Products
The 2022 revision. Contamination Control Strategy as an explicit requirement, barrier technology expectations, and a rewritten approach to environmental monitoring and aseptic process simulation.
Annex 2
Manufacture of Biological Active Substances and Medicinal Products for Human Use
Biologics-specific GMP, including seed lot and cell bank systems.
Annex 3
Manufacture of Radiopharmaceuticals
GMP where the product decays while you test it.
Annex 6
Manufacture of Medicinal Gases
GMP for medicinal gases, where the product is piped rather than filled and the container is refilled rather than replaced.
Annex 8
Sampling of Starting and Packaging Materials
Sampling plans for starting and packaging materials, including when identity must be confirmed on every container.
Annex 11
Computerized Systems
The EU counterpart to 21 CFR Part 11, but written around risk management, supplier assessment, data lifecycle and periodic review rather than around signatures.
Annex 13
Manufacture of Investigational Medicinal Products
GMP for clinical trial supplies, including labeling and randomization code handling.
Annex 14
Manufacture of Medicinal Products Derived from Human Blood or Plasma
Plasma-derived products: donor selection, plasma master file, and the traceability that has to run from donor to patient.
Annex 15
Qualification and Validation
URS through DQ, IQ, OQ, PQ, process validation, cleaning validation and change control. The document most validation master plans are structured around.
Annex 16
Certification by a Qualified Person and Batch Release
What the QP is certifying, and what they may rely on when doing it. There is no US equivalent role.
Annex 17
Real Time Release Testing and Parametric Release
When a measured process parameter may replace an end-product test.
Annex 19
Reference and Retention Samples
How many reference and retention samples to keep, for how long, and the difference between the two.
Annex 21
Importation of Medicinal Products
Obligations of the importing site and the QP for products arriving from outside the EU.
Regulation (EU) 536/2014
Clinical Trials Regulation
Replaced the Clinical Trials Directive. Single submission through CTIS, and coordinated assessment across member states.
Regulation (EU) 2017/745
Medical Device Regulation
MDR. Replaced the Medical Devices Directive, with a wider scope and much heavier clinical evidence requirements.
Regulation (EU) 2017/746
In Vitro Diagnostic Regulation
IVDR, the diagnostics counterpart to MDR.
Directive 2001/83/EC
Community Code Relating to Medicinal Products for Human Use
The foundational EU medicines directive, including the content of a marketing authorization application.
Regulation (EC) 1234/2008
Variations Regulation
The EU post-approval change framework: Type IA, IAin, IB and II variations, and line extensions.
EMA Guideline on Process Validation
Process Validation for Finished Products
The EU expectation for traditional, continuous process verification, and hybrid approaches.
Annex 4
Manufacture of Veterinary Medicinal Products other than Immunologicals
GMP for veterinary products other than immunologicals, including medicated premixes.
Annex 5
Manufacture of Immunological Veterinary Medicinal Products
GMP for veterinary vaccines and other immunologicals, where seed lots and animal facilities come into it.
Annex 7
Manufacture of Herbal Medicinal Products
Herbal starting materials, where the plant, the harvest and the extract all carry quality attributes.
Annex 9
Manufacture of Liquids, Creams and Ointments
Non-sterile liquids, creams and ointments: homogeneity, microbial control and the risk of contamination during transfer.
Annex 10
Manufacture of Pressurized Metered Dose Aerosol Preparations for Inhalation
Pressurised metered dose inhalers, covering propellant, valve and the clean area the suspension is filled in.
Annex 12
Use of Ionizing Radiation in the Manufacture of Medicinal Products
Gamma and electron beam sterilization: dosimetry, dose setting and the validation behind an irradiation contract.
Annex 20
Quality Risk Management
Superseded in practice by ICH Q9, which EudraLex now points to. Kept here because older documents still cite it.
EU GMP Part II
Basic Requirements for Active Substances used as Starting Materials
The API side of EudraLex Volume 4, aligned with ICH Q7.
EU GMP Part III
GMP Related Documents
Site master file, ICH Q9 and Q10 as adopted, and the MRA batch certificate template.
Regulation (EU) 2019/6
Veterinary Medicinal Products
The veterinary medicinal products regulation, which took veterinary products out of Directive 2001/82/EC.
Regulation (EC) 726/2004
Centralized Procedure
The regulation establishing the EMA and the centralized marketing authorization route.
Regulation (EC) 1394/2007
Advanced Therapy Medicinal Products
The regulation that defines an ATMP and sets the route for gene, cell and tissue engineered products.

USP chapters · 57

USP <51>
Antimicrobial Effectiveness Testing
Preservative efficacy: the challenge organisms and the log reduction expected over time by product category.
USP <61>
Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Total aerobic microbial count and total combined yeasts and molds.
USP <62>
Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
Absence of the objectionable organisms for the route of administration.
USP <71>
Sterility Tests
Membrane filtration and direct inoculation, incubation periods, and the sampling plan.
USP <85>
Bacterial Endotoxins Test
LAL methods: gel clot, turbidimetric and chromogenic, and the endotoxin limit calculation from K/M.
USP <87> / <88>
Biological Reactivity Tests, In Vitro and In Vivo
Materials biocompatibility screening, including the Class I to VI plastics classification.
USP <197>
Spectrophotometric Identification Tests
Identification by infrared or ultraviolet absorption, including the sample preparation each form of the test requires.
USP <232> / <233>
Elemental Impurities: Limits / Procedures
The compendial implementation of ICH Q3D: the limits, and the ICP-OES and ICP-MS procedures with their validation expectations.
USP <381>
Elastomeric Components in Injectable Product Packaging
Closures: physicochemical and functionality testing.
USP <467>
Residual Solvents
The compendial counterpart to ICH Q3C.
USP <621>
Chromatography
System suitability, and the allowable adjustments to a chromatographic method that do not require revalidation.
USP <643> / <645>
Total Organic Carbon / Water Conductivity
The two tests that define pharmaceutical water quality.
USP <661.1> / <661.2>
Plastic Materials of Construction / Plastic Packaging Systems for Pharmaceutical Use
Materials characterization and packaging system suitability.
USP <695>
Crystallinity
Degree of crystallinity, which matters wherever a polymorph or an amorphous dispersion is part of the control strategy.
USP <711>
Dissolution
Apparatus 1 through 4, media, and the acceptance tables S1, S2, S3.
USP <724>
Drug Release
Dissolution for modified release dosage forms.
USP <787> / <788> / <789>
Subvisible Particulate Matter
Light obscuration and microscopic counts, for therapeutic protein injections, injections generally, and ophthalmic solutions.
USP <790>
Visible Particulates in Injections
Essentially free from visible particulates, and the inspection process behind that phrase.
USP <797> / <795> / <800>
Compounding: Sterile / Nonsterile / Hazardous Drugs
Pharmacy compounding standards, including the handling of hazardous drugs.
USP <905>
Uniformity of Dosage Units
Content uniformity and weight variation, and the L1 and L2 acceptance values.
USP <1058>
Analytical Instrument Qualification
The four Qs, DQ, IQ, OQ, PQ, and the data quality triangle that puts AIQ underneath method validation and system suitability.
USP <1207>
Package Integrity Evaluation: Sterile Products
Container closure integrity testing, and the shift away from microbial immersion toward deterministic physical methods.
USP <1211>
Sterility Assurance
The framework: sterilization process design, SAL, and why a sterility test is not how you assure sterility.
USP <1223>
Validation of Alternative Microbiological Methods
How to show a rapid method is equivalent to the compendial one.
USP <1225> / <1226>
Validation of Compendial Procedures / Verification of Compendial Procedures
Validate a method you developed; verify a compendial method under your own conditions. Confusing these two is a common finding.
USP <1229>
Sterilization of Compendial Articles
The parent chapter for the sterilization sub-chapters, including moist heat, dry heat, radiation and filtration.
USP <1220>
Analytical Procedure Life Cycle
The chapter that reframes a method as something with a lifecycle: an analytical target profile, then design, qualification and ongoing performance verification, mirroring process validation's three stages. The counterpart to ICH Q14.
USP <1210>
Statistical Tools for Procedure Validation
The statistics behind validation: how to demonstrate accuracy and precision against the target rather than merely report them.
USP <1224>
Transfer of Analytical Procedures
Comparative testing, co-validation, revalidation or waiver, and what each one obliges you to show.
USP <1225>
Validation of Compendial Procedures
The performance characteristics a non-compendial procedure has to demonstrate.
USP <1226>
Verification of Compendial Procedures
What you still have to prove when using a compendial method in your own laboratory with your own matrix.
USP <63>
Mycoplasma Tests
Culture and nucleic acid based detection of mycoplasma in cell substrates and cell therapy products.
USP <88>
Biological Reactivity Tests, In Vivo
The in vivo plastics classification behind USP Class VI materials.
USP <660>
Containers: Glass
Glass types, hydrolytic resistance and the tests that assign them.
USP <661>
Plastic Packaging Systems and Their Materials of Construction
The framework chapter over <661.1> and <661.2>.
USP <661.1>
Plastic Materials of Construction
Identification and characterization of the plastic itself, before it becomes a component.
USP <661.2>
Plastic Packaging Systems for Pharmaceutical Use
The assembled system, tested as the patient will meet it.
USP <1663>
Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
How to design an extractables study that will actually inform the leachables one.
USP <1664>
Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
Leachables in the real product over the real shelf life, and the thresholds that decide what matters.
USP <1072>
Disinfectants and Antiseptics
Selection, rotation and the coupon studies that qualify a disinfectant against your own surfaces and isolates.
USP <1112>
Application of Water Activity Determination to Nonsterile Pharmaceutical Products
Water activity as the argument for reduced microbial testing on a formulation that cannot support growth.
USP <1116>
Microbiological Control and Monitoring of Aseptic Processing Environments
Contamination recovery rates, how to interpret them, and why a single excursion is not a trend.
USP <1231>
Water for Pharmaceutical Purposes
The long chapter behind every water system: generation, distribution, sanitization, and what to monitor.
USP <1086>
Impurities in Drug Substances and Drug Products
The compendial view of impurities, alongside ICH Q3A and Q3B.
USP <921>
Water Determination
Karl Fischer, titrimetric and azeotropic, and which to use when.
USP <941>
Characterization of Crystalline and Partially Crystalline Solids by X-Ray Powder Diffraction
XRPD for polymorph identity, and for showing an amorphous dispersion is still amorphous.
USP <736>
Mass Spectrometry
Compendial mass spectrometry, including the requirements behind nitrosamine and elemental methods.
USP <1079>
Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
Cold chain and ambient distribution risk, and the mitigations expected to be in place before a lane runs.
USP <1083>
Supply Chain Integrity
Diversion, falsification and the controls across a distribution network.
USP <1046>
Cellular and Tissue-Based Products
The compendial framing of a living product: donor, process, potency and comparability.
USP <1047>
Gene Therapy Products
Vectors, transduction and the analytical package a gene therapy needs.
USP <1043>
Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
The reagents that touch the product without being in it, and the qualification tiers they fall into.
USP <1044>
Cryopreservation of Cells
Freezing, storage and thaw for a product whose viability is the specification.
USP <1237>
Virology Test Methods
Adventitious agent and viral clearance methods for biologics.
USP <1238>
Vaccines for Human Use
Characterization and control across vaccine platforms.
USP <800>
Hazardous Drugs: Handling in Healthcare Settings
Containment for hazardous drugs from receipt to administration.
USP <825>
Radiopharmaceuticals: Preparation, Compounding, Dispensing, and Repackaging
Short half-life products, where release happens against the clock.

PDA reports · 79

PDA TR 1
Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control (Revised 2007)
Cycle design, qualification and ongoing control for steam sterilization, overkill and bioburden based.
PDA TR 3
Validation of Dry Heat Processes Used for Depyrogenation and Sterilization (Revised 2013)
Dry heat, including the three log reduction of endotoxin expected from a depyrogenation tunnel.
PDA TR 12
Siliconization of Parenteral Drug Packaging Components (1988)
Silicone on glass and elastomer: why it is there, how much, and what it does to particulate and to protein.
PDA TR 13
Fundamentals of an Environmental Monitoring Program (Revised 2022)
Site selection, frequency, alert and action levels, and how to read a trend rather than a single plate.
PDA TR 13-2
Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products (2020)
Monitoring where the product is not sterile but bioburden still has to be held down.
PDA TR 14
Validation of Column-Based Chromatography Processes for the Purification of Proteins (Revised 2008)
Resin lifetime, cleaning, carryover and the small-scale model that has to justify all three.
PDA TR 15
Validation of Tangential Flow Filtration in Biopharmaceutical Applications (Revised 2009)
Qualification of TFF for concentration and diafiltration: integrity, cleaning, reuse and scale.
PDA TR 22
Process Simulation for Aseptically Filled Products (Revised 2025)
Media fill design: number of units, interventions, incubation, and what a single positive obliges you to do.
PDA TR 26
Sterilizing Filtration of Liquids (Revised 2025)
Filter validation: bacterial challenge with Brevundimonas diminuta, extractables, and product-specific bubble point.
PDA TR 27
Pharmaceutical Package Integrity (1998)
The package as a barrier, and the test methods that demonstrate it holds.
PDA TR 28
Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals (Revised 2006)
Media simulation for sterile bulk API, where the scale and the vessel are nothing like a filling line.
PDA TR 29
Points to Consider for Cleaning Validation (Revised 2012)
Limits, sampling, recovery studies, and the move toward health-based exposure limits.
PDA TR 30
Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat (Revised 2012)
Releasing on the physics of the cycle instead of waiting fourteen days for a sterility test.
PDA TR 33
Evaluation, Validation, and Implementation of Alternative and Rapid Microbiological Methods (Revised 2013)
The framework for qualifying a rapid method against the compendial one it is meant to replace.
PDA TR 34
Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products (2001)
Isolators: glove integrity, decontamination cycle development, and the leak rate that defines the barrier.
PDA TR 38
Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing, and Controls Documentation (2006)
What a change to a chromatography step obliges you to file, and what it does not.
PDA TR 39
Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment (Revised 2021)
Cold chain distribution qualification and excursion management, lane by lane.
PDA TR 40
Sterilization Filtration of Gases (2005)
Gas filtration: vent filters, hydrophobicity, integrity testing in place and the effect of condensate.
PDA TR 41
Virus Filtration (Revised 2022)
Small virus retentive filtration: sizing, integrity testing and validation of retention.
PDA TR 43
Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing: Covering Ampoules, Bottles, Cartridges, Syringes and Vials (Revised 2023)
A shared vocabulary for glass defects, so a container specification means the same thing on both sides of the contract.
PDA TR 44
Quality Risk Management for Aseptic Processes (2008)
ICH Q9 applied specifically to aseptic manufacturing.
PDA TR 45
Filtration of Liquids Using Cellulose-Based Depth Filters (2008)
Depth filtration: mechanism, sizing and validation for clarification.
PDA TR 46
Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User (Revised 2024)
The leg nobody qualifies: pharmacy, clinic and patient, after the validated lane ends.
PDA TR 47
Preparation of Virus Spikes Used for Virus Clearance Studies (2010)
The spike itself: propagation, purification and titre, since a clearance claim is only as good as what you spiked.
PDA TR 48
Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance (2010)
The autoclave itself rather than the cycle: the system around the sterilization that TR 1 describes.
PDA TR 49
Points to Consider for Biotechnology Cleaning Validation (2010)
Protein-specific cleaning: degradation as an advantage, and TOC as the practical limit.
PDA TR 50
Alternative Methods for Mycoplasma Testing (2010)
Nucleic acid based mycoplasma detection, and what it takes to have one accepted in place of culture.
PDA TR 51
Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use (2010)
Selection, use and control of biological indicators for vapor-phase decontamination.
PDA TR 52
Guidance for Good Distribution Practices (GDPs) for the Pharmaceutical Supply Chain (2011)
Good distribution practice across the chain: qualification of routes, packaging and the people handling it.
PDA TR 53
Guidance for Industry: Stability Testing to Support Distribution of New Drug Products (2011)
Stability data aimed at what distribution actually does to a product, rather than at shelf life alone.
PDA TR 54
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations (2012)
Turning ICH Q9 into working practice: tool selection, and when a formal assessment is worth the time.
PDA TR 54-2
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling (2013)
Worked packaging and labeling risk assessments, where the failure is usually a mix-up.
PDA TR 54-3
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products (2013)
Worked drug product risk assessments, taken through to the control they justify.
PDA TR 54-4
Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances (2014)
The same, for a biological drug substance, where the process defines the product.
PDA TR 54-5
Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (2017)
Risk assessment applied to equipment and facility systems, which is where ASTM E2500 meets ICH Q9.
PDA TR 54-6
Formalized Risk Assessment for Excipients (2019)
Excipient risk: supplier, origin, function and what the formulation will forgive.
PDA TR 55
Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries (2012)
The haloanisole taint problem: where it comes from, how it reaches product, and how to keep it out.
PDA TR 56
Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (Revised 2016)
What a quality system has to carry at each clinical phase, rather than commercial expectations from day one.
PDA TR 57
Analytical Method Validation and Transfer for Biotechnology Products (2012)
Transfer designs and the statistics that decide whether a transfer passed.
PDA TR 57-2
Analytical Method Development and Qualification for Biotechnology Products (2015)
The stage before validation: developing a method and qualifying it for the phase it will support.
PDA TR 58
Risk Management for Temperature-Controlled Distribution (2012)
Risk assessment for the cold chain, complementing ICH Q9 rather than repeating it.
PDA TR 59
Utilization of Statistical Methods for Production Monitoring (2012)
Control charts and capability applied to production data, which is stage 3 validation in practice.
PDA TR 60
Process Validation: A Lifecycle Approach (2026)
The PDA reading of the three stages: process design, process qualification, continued verification.
PDA TR 60-2
Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (2017)
The oral solid and semisolid annex to TR 60, blend uniformity through to content uniformity.
PDA TR 60-3
Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing (2021)
The biologics annex, where the process is the product and validation has to say so.
PDA TR 61
Steam In Place (2013)
SIP: design, qualification and routine control of a cycle run on installed equipment.
PDA TR 62
Recommended Practices for Manual Aseptic Processes (2013)
Manual aseptic operations, where the operator is the largest contamination risk in the room.
PDA TR 63
Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials (2013)
Preparation at the clinical site, which sits outside the manufacturing quality system but not outside quality.
PDA TR 64
Active Temperature-Controlled Systems: Qualification Guidance (2024)
Active containers and reefers: qualification of the system rather than of a single shipment.
PDA TR 65
Technology Transfer (2022)
What a transfer package must contain, and how to show the receiving site can actually run it.
PDA TR 66
Application of Single-Use Systems in Pharmaceutical Manufacturing (2014)
Extractables and leachables, integrity, supplier qualification and change control for disposables.
PDA TR 67
Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics (2014)
What makes an organism objectionable for a given product and route, rather than a fixed list.
PDA TR 68
Risk-Based Approach for Prevention and Management of Drug Shortages (2024)
Shortage risk as a quality problem: single sources, capacity, and the early signals of one.
PDA TR 69
Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations (2015)
Where biofilm establishes itself in process systems, and what actually removes it.
PDA TR 70
Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities (2015)
Agent rotation, contact time and the coupon studies behind a disinfectant claim.
PDA TR 71
Emerging Methods for Virus Detection (2015)
Broad-range molecular methods for adventitious agents, and what they can and cannot replace.
PDA TR 72
Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance (2015)
Passive shippers: thermal qualification, payload configuration and the operating procedure that keeps it valid.
PDA TR 73
Prefilled Syringe User Requirements for Biotechnology Applications (2015)
User requirements for the 1 mL long glass prefilled syringe, component by component.
PDA TR 73-2
Application of Medical Device Regulations, Annex I Requirements (GSPRs) for Staked Needle Syringes (2024)
Meeting the EU device general safety and performance requirements for a staked needle syringe.
PDA TR 74
Reprocessing and Reworking of Biologicals (2026)
When reprocessing is acceptable, what has to be demonstrated, and how it is filed.
PDA TR 75
Consensus Method for Rating 0.1 micron Mycoplasma Reduction Filters (2016)
A common challenge method, so that a 0.1 micron rating means the same thing between suppliers.
PDA TR 76
Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (2016)
The stopper and seal counterpart to TR 43's glass defect vocabulary.
PDA TR 77
The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (2017)
BFS as its own aseptic process: the parison, the critical zone, and what qualification looks like.
PDA TR 78
Particulate Matter in Oral Dosage Forms (2017)
Particulate in solid oral products, which the injectable chapters do not cover.
PDA TR 79
Particulate Matter Control in Difficult to Inspect Parenterals (2018)
Lyophilized cake, suspensions and amber glass, where visual inspection cannot see what it needs to.
PDA TR 80
Data Integrity Management System for Pharmaceutical Laboratories (2018)
ALCOA+ made concrete in a QC laboratory: systems, roles, audit trail review and governance.
PDA TR 81
Cell-Based Therapy Control Strategy (2019)
A control strategy for a living product, where the batch is one patient and the process defines it.
PDA TR 82
Low Endotoxin Recovery (2019)
Why endotoxin can disappear in a formulation matrix, and what a hold-time study has to demonstrate.
PDA TR 83
Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (2019)
Prevention, detection and what to do on the day a bioreactor is positive.
PDA TR 84
Integrating Data Integrity Requirements into Manufacturing and Packing Operations (2020)
Data integrity on the floor rather than in the laboratory, where the records are often still paper.
PDA TR 85
Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers (2021)
Counting particles on the component before it ever reaches the line.
PDA TR 86
Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (2021)
Deterministic CCIT methods and where each is defensible, alongside USP <1207>.
PDA TR 87
Current Best Practices for Pharmaceutical Glass Vial Handling and Processing (2021)
Glass handling from depyrogenation tunnel to capping, and the damage each step can do.
PDA TR 88
Microbial Data Deviation Investigations in the Pharmaceutical Industry (2022)
Investigating a microbial excursion without reaching for a foregone conclusion.
PDA TR 89
Strategies for Vaccine Development and Lifecycle Management (2023)
Vaccine platforms and what changes across the lifecycle of one, including strain change.
PDA TR 90
Contamination Control Strategy Development in Pharmaceutical Manufacturing (2023)
How to build the contamination control strategy Annex 1 now requires, rather than assembling one after the fact.
PDA TR 91
Post-Approval Change Management and Implementation for Biologics and Pharmaceutical Drug Products: A User's Guide (2023)
Working ICH Q12 in practice: established conditions, change protocols and what each market will actually accept.
PDA TR 7
Depyrogenation (1985)
Archived by PDA and not in the current catalogue. Depyrogenation of solutions, containers and devices; TR 3 now carries dry heat depyrogenation. Listed because older documents still cite it.
PDA TR 42
Process Validation of Protein Manufacturing (2005)
Archived by PDA and not in the current catalogue. Superseded in practice by TR 60 and its biologics annex TR 60-3. Listed because older documents still cite it.

ISO & ASTM · 20

ISO 9001
Quality Management Systems: Requirements
The generic QMS standard. ICH Q10 was written with it in view.
ISO 13485
Medical Devices: Quality Management Systems
The device QMS standard, now folded into the US QMSR by reference.
ISO 14971
Medical Devices: Application of Risk Management to Medical Devices
Device risk management, and the source of much of the risk vocabulary used more widely.
ISO 14644
Cleanrooms and Associated Controlled Environments
Cleanroom classification. Part 1 covers classification by particle concentration, which is where ISO 5 through ISO 8 come from.
ISO 11137
Sterilization of Health Care Products: Radiation
Dose setting and dose auditing for radiation sterilization.
ISO 17665
Sterilization of Health Care Products: Moist Heat
Moist heat sterilization of health care products: development, validation and routine control of the process.
ISO 11135
Sterilization of Health Care Products: Ethylene Oxide
Ethylene oxide sterilization, including the residuals limits that follow from it.
ISO 10993
Biological Evaluation of Medical Devices
The biocompatibility series, including cytotoxicity, sensitization and irritation.
ISO 11737
Sterilization of Health Care Products: Microbiological Methods
Bioburden determination and sterility test of processed product.
ISO 20417 / ISO 15223
Information Supplied by the Manufacturer / Symbols
Labeling requirements and the harmonized symbols used on device labels.
ASTM E2500
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
The science and risk-based alternative to a rigid IQ/OQ/PQ sequence. The intellectual basis for the ISPE commissioning and qualification approach.
ASTM E2709 / E2810
Statistical Approach for Demonstrating Probability of Passing an Acceptance Procedure
The mathematics behind content uniformity acceptance and process capability claims.
ISO 11607
Packaging for Terminally Sterilized Medical Devices
Sterile barrier systems: validation of forming, sealing and assembly, and stability of the barrier.
ISO 13408
Aseptic Processing of Health Care Products
The ISO series covering aseptic processing, filtration, lyophilization and single-use systems.
ISO 15378
Primary Packaging Materials for Medicinal Products
ISO 9001 with GMP requirements, applied to the people who make your vials, stoppers and blisters.
ISO 14155
Clinical Investigation of Medical Devices for Human Subjects
Good clinical practice for device studies, the device counterpart to ICH E6.
IEC 62304
Medical Device Software: Software Life Cycle Processes
Software safety classification and the lifecycle obligations that follow from it.
IEC 60601
Medical Electrical Equipment
The safety and essential performance series behind any powered delivery device.
ISO 11040
Prefilled Syringes
Prefilled syringes: barrel, plunger, needle shield and the dimensional and functional requirements across them.
ISO 8871
Elastomeric Parts for Parenterals
Elastomeric closures for parenterals: extractables, fragmentation, self-sealing and penetration force.

WHO, PIC/S, ISPE · 5

WHO TRS
WHO Technical Report Series
WHO GMP and related annexes, which matter for prequalification and for many national regulators who adopt them directly.
WHO PQ
WHO Prequalification Program
The route by which a product becomes procurable by UN agencies.
PIC/S GMP Guide
Pharmaceutical Inspection Co-operation Scheme
A GMP guide closely aligned with EU GMP, used by inspectorates across more than fifty jurisdictions.
ISPE Baseline Guides
International Society for Pharmaceutical Engineering
Facility and system design guidance, including the Commissioning and Qualification guide that operationalises ASTM E2500.
GAMP 5
Good Automated Manufacturing Practice, Second Edition
Computerized system validation by risk and by software category, from infrastructure through configured products to bespoke code.

Acronyms · 678

ANVISA
Agência Nacional de Vigilância Sanitária, the Brazilian health regulator
CBER
Center for Biologics Evaluation and Research, the FDA center for biologics, vaccines, blood and cell and gene therapy
CDER
Center for Drug Evaluation and Research, the FDA center for drugs including most therapeutic proteins
CDRH
Center for Devices and Radiological Health, the FDA device center
CDE
Center for Drug Evaluation, the review body under China's NMPA
CDSCO
Central Drugs Standard Control Organization, the Indian regulator
CHMP
Committee for Medicinal Products for Human Use, the EMA scientific committee that gives the opinion on a marketing authorization
EDQM
European Directorate for the Quality of Medicines, publisher of the European Pharmacopoeia and issuer of CEPs
EMA
European Medicines Agency
FDA
Food and Drug Administration
HC
Health Canada
ICH
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
MHRA
Medicines and Healthcare products Regulatory Agency, the UK regulator
MFDS
Ministry of Food and Drug Safety, the Korean regulator
NMPA
National Medical Products Administration, the Chinese regulator
PMDA
Pharmaceuticals and Medical Devices Agency, the Japanese regulator
PIC/S
Pharmaceutical Inspection Co-operation Scheme
TGA
Therapeutic Goods Administration, the Australian regulator. Not to be confused with thermogravimetric analysis, which shares the abbreviation
USP
United States Pharmacopeia. Not to be confused with upstream processing, which shares the abbreviation
Ph. Eur. / EP
European Pharmacopoeia
JP
Japanese Pharmacopoeia
BP
British Pharmacopoeia
WHO
World Health Organization
PDA
Parenteral Drug Association
ISPE
International Society for Pharmaceutical Engineering
AAMI
Association for the Advancement of Medical Instrumentation
USAN / INN
United States Adopted Name / International Nonproprietary Name, the generic name of a drug substance
ANDA
Abbreviated New Drug Application, the US generic pathway
aBLA
Abbreviated Biologics License Application, the 351(k) biosimilar pathway
BLA
Biologics License Application
CEP
Certificate of Suitability to the monographs of the European Pharmacopoeia
CTA
Clinical Trial Application, the EU and UK equivalent of an IND
CTD
Common Technical Document, the five-module structure of a submission
eCTD
Electronic Common Technical Document, the submission format itself
DMF / ASMF
Drug Master File / Active Substance Master File, a confidential dossier a supplier files so a sponsor can reference it without seeing it
EOP2
End of Phase 2 meeting with the agency
IND
Investigational New Drug application
IMPD
Investigational Medicinal Product Dossier, the EU quality package for a clinical trial
MAA
Marketing Authorization Application, the EU equivalent of an NDA or BLA
NDA
New Drug Application. Not to be confused with a non-disclosure agreement, which shares the abbreviation
NDS
New Drug Submission, the Canadian equivalent
PAS
Prior Approval Supplement, a post-approval change you may not implement until the agency agrees
CBE-30 / CBE-0
Changes Being Effected in 30 days, or immediately, the two lower US post-approval reporting categories
PACMP
Post-Approval Change Management Protocol, an agreed plan for a future change, from ICH Q12
PLCM
Product Lifecycle Management document, the ICH Q12 summary of established conditions and reporting categories
EC
Established Conditions, the elements of a process legally binding once approved, from ICH Q12
BTD
Breakthrough Therapy Designation
RMAT
Regenerative Medicine Advanced Therapy designation
PRIME
PRIority MEdicines, the EMA accelerated support scheme
ODD
Orphan Drug Designation
PSP / PIP
Pediatric Study Plan / Paediatric Investigation Plan, the US and EU paediatric commitments
PDUFA
Prescription Drug User Fee Act, and by extension the action date it sets
CRL
Complete Response Letter, the FDA's refusal to approve in its current form
483
FDA Form 483, the list of inspectional observations issued at the end of an inspection
EIR
Establishment Inspection Report
OAI / VAI / NAI
Official Action Indicated, Voluntary Action Indicated, No Action Indicated, the three inspection outcomes
PAI
Pre-Approval Inspection
BIMO
Bioresearch Monitoring, the FDA program that inspects clinical sites and sponsors
GDUFA / BsUFA
Generic Drug and Biosimilar User Fee Acts
ALCOA+
Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available. The data integrity principles
APR / PQR
Annual Product Review / Product Quality Review, the yearly retrospective look at a product's batches and trends
CAPA
Corrective and Preventive Action
cGMP
current Good Manufacturing Practice. The current is doing real work: it means the standard moves
GxP
The collective term for GMP, GCP, GLP, GDP and GVP
GCP
Good Clinical Practice
GLP
Good Laboratory Practice, which governs nonclinical safety studies and not the QC laboratory
GDP
Good Distribution Practice
GVP
Good Pharmacovigilance Practice
GACP
Good Agricultural and Collection Practice, for botanical starting materials
GTP
Good Tissue Practice, under 21 CFR 1271
DI
Data Integrity
OOS / OOT / OOE
Out Of Specification, Out Of Trend, Out Of Expectation. Only the first is a specification failure; the others are signals
QA
Quality Assurance
QC
Quality Control
QCU
Quality Control Unit, the 21 CFR 211.22 role with authority to approve or reject
QMS
Quality Management System
PQS
Pharmaceutical Quality System, the ICH Q10 term
QP
Qualified Person, the named individual who certifies each EU batch. There is no US equivalent
QRM
Quality Risk Management, ICH Q9
FMEA / FMECA
Failure Mode and Effects Analysis, with Criticality. The most used QRM tool, and the most often misused
HACCP
Hazard Analysis and Critical Control Points
RPN
Risk Priority Number, severity times occurrence times detectability. Ordinal numbers multiplied together, which is why it should never be the whole answer
FTA
Fault Tree Analysis
SOP
Standard Operating Procedure
MBR / EBR
Master Batch Record / Electronic Batch Record
BMR / BPR
Batch Manufacturing Record / Batch Production Record
CoA
Certificate of Analysis
CoC / CoO
Certificate of Compliance / Certificate of Origin. Not to be confused with chain of custody, which shares the abbreviation
SME
Subject Matter Expert
RCA
Root Cause Analysis
CC
Change Control
MRA
Mutual Recognition Agreement, under which one regulator accepts another's GMP inspections
HBEL / PDE / ADE
Health Based Exposure Limit, Permitted Daily Exposure, Acceptable Daily Exposure. The toxicology-derived basis for cleaning limits
MACO
Maximum Allowable Carryover, the cleaning validation limit
TOC
Total Organic Carbon, the workhorse cleaning and water measurement
QbD
Quality by Design
QTPP
Quality Target Product Profile, the prospective summary of what the product must be
TPP
Target Product Profile, the clinical and commercial version of the same idea
CQA
Critical Quality Attribute, a property that must be within a limit to assure product quality
CPP
Critical Process Parameter, a parameter whose variation affects a CQA
CMA
Critical Material Attribute, the input equivalent of a CPP
PAR
Proven Acceptable Range, a range shown acceptable while other parameters were held constant
NOR
Normal Operating Range, where you actually run, inside the PAR
DS / DP
Drug Substance / Drug Product
API
Active Pharmaceutical Ingredient
DoE
Design of Experiments
OFAT
One Factor At a Time, the approach DoE replaces, and the reason interactions get missed
MODR
Method Operable Design Region, the analytical analogue of a design space, from ICH Q14
ATP
Analytical Target Profile, what a method must deliver before you design it
CCS
Contamination Control Strategy, the Annex 1 requirement to describe control as one connected system
CPV
Continued Process Verification, stage 3 of process validation
PPQ
Process Performance Qualification, stage 2 of process validation
PV
Process Validation. Not to be confused with pharmacovigilance, which shares the abbreviation
CSV / CSA
Computer System Validation / Computer Software Assurance, the newer risk-based framing of the same obligation
URS
User Requirement Specification
DQ / IQ / OQ / PQ
Design, Installation, Operational and Performance Qualification
FAT / SAT
Factory and Site Acceptance Testing
C&Q
Commissioning and Qualification
VMP
Validation Master Plan
TT
Technology Transfer
RTRT
Real Time Release Testing
PAT
Process Analytical Technology
CM
Continuous Manufacturing, ICH Q13
RTD
Residence Time Distribution, which is how a continuously manufactured batch is traced
SPC
Statistical Process Control. Not to be confused with a supplementary protection certificate, which shares the abbreviation
Cp / Cpk / Ppk
Process capability indices. Cpk accounts for how far off center the process is; Ppk uses overall rather than within-subgroup variation
HPLC / UPLC / UHPLC
High and Ultra Performance Liquid Chromatography
GC / GC-MS
Gas Chromatography, with Mass Spectrometry
LC-MS / LC-MS/MS
Liquid Chromatography Mass Spectrometry, and the tandem form used for quantitation
SEC / SEC-MALS
Size Exclusion Chromatography, with Multi Angle Light Scattering for absolute molar mass
AEX / CEX
Anion and Cation Exchange chromatography
HIC
Hydrophobic Interaction Chromatography
RP-HPLC
Reversed Phase HPLC
IEF / cIEF
Isoelectric Focusing, and its capillary form, for charge variants
CE / CE-SDS
Capillary Electrophoresis, and the SDS form that has largely replaced the SDS-PAGE purity gel
ELISA
Enzyme Linked Immunosorbent Assay
SPR / BLI
Surface Plasmon Resonance / Bio-Layer Interferometry, for binding kinetics
DSC / DSF
Differential Scanning Calorimetry / Fluorimetry, for conformational stability
DLS
Dynamic Light Scattering, for size distribution and aggregation
AUC
Analytical Ultracentrifugation, the orthogonal method for aggregate quantitation
CD
Circular Dichroism, for secondary and tertiary structure
FTIR / NIR / Raman
Infrared, Near Infrared and Raman spectroscopy. The three that carry most PAT applications
NMR
Nuclear Magnetic Resonance
ICP-OES / ICP-MS
Inductively Coupled Plasma spectroscopy, the elemental impurity workhorses
KF
Karl Fischer titration, for water content
TGA
Thermogravimetric Analysis, for solid state characterization. Not to be confused with the Australian regulator, which shares the abbreviation
XRPD / PXRD
X-Ray Powder Diffraction, for polymorph identity
PSD
Particle Size Distribution
LOD / LOQ
Limit of Detection / Limit of Quantitation
RSD / %RSD
Relative Standard Deviation, the precision measure
SST
System Suitability Testing, the check that the instrument was fit at the moment of use
RS / WS
Reference Standard / Working Standard
MVDA
Multivariate Data Analysis
PCA / PLS
Principal Component Analysis / Partial Least Squares
AIQ
Analytical Instrument Qualification, USP <1058>
MSA
Measurement System Analysis. Not to be confused with a master services agreement, which shares the abbreviation
HCP / HCD
Host Cell Protein / Host Cell DNA, the two process-related impurities every biologic must control
E&L
Extractables and Leachables
CCIT
Container Closure Integrity Testing
LAL / BET
Limulus Amebocyte Lysate / Bacterial Endotoxins Test
rFC
recombinant Factor C, the animal-free endotoxin test alternative
TAMC / TYMC
Total Aerobic Microbial Count / Total Yeast and Mold Count
RMM
Rapid Microbiological Method
qPCR / ddPCR
Quantitative and droplet digital PCR
NGS
Next Generation Sequencing, increasingly used for adventitious agent testing
MFI
Micro-Flow Imaging, for subvisible particles
FACS
Fluorescence Activated Cell Sorting
PK / PD
Pharmacokinetics / Pharmacodynamics
ADA / NAb
Anti-Drug Antibody / Neutralizing Antibody, the immunogenicity readouts
USP
Upstream Processing, with DSP for downstream. Not to be confused with the United States Pharmacopeia, which shares the abbreviation
MCB / WCB
Master Cell Bank / Working Cell Bank
EPC
End of Production Cells, tested to confirm genetic stability at the limit of in vitro cell age
CHO
Chinese Hamster Ovary cells, the dominant mammalian expression host
HEK293
Human Embryonic Kidney 293 cells, common for viral vector production
UF/DF
Ultrafiltration and Diafiltration, the concentration and buffer exchange step
TFF
Tangential Flow Filtration
VI / VF
Viral Inactivation / Viral Filtration, the two dedicated viral clearance steps
LRV
Log Reduction Value, the unit of clearance
SUS / SUT
Single Use Systems / Technologies
WFI / PW
Water For Injection / Purified Water
CIP / SIP
Clean In Place / Steam In Place
HVAC
Heating, Ventilation and Air Conditioning, which in a cleanroom is a GMP-critical system
HEPA
High Efficiency Particulate Air filter
RABS
Restricted Access Barrier System
VHP
Vaporized Hydrogen Peroxide, the usual isolator decontamination agent
APS
Aseptic Process Simulation, the media fill
EM
Environmental Monitoring
SAL
Sterility Assurance Level, conventionally ten to the minus six for a terminally sterilized product
F0
The equivalent time at 121 degrees Celsius delivered by a moist heat cycle
D-value / z-value
The time for a one log reduction at a given temperature, and the temperature change for a tenfold change in D
BI
Biological Indicator
OEL / OEB
Occupational Exposure Limit / Band, which drives containment design
ADC
Antibody Drug Conjugate
mAb / bsAb
Monoclonal Antibody / Bispecific Antibody
AAV / LV
Adeno-Associated Virus / Lentiviral vector
CAR-T
Chimeric Antigen Receptor T cell therapy
ATMP
Advanced Therapy Medicinal Product, the EU class covering gene therapy, somatic cell therapy and tissue engineered products
CGT
Cell and Gene Therapy
mRNA / LNP
Messenger RNA and the Lipid Nanoparticle that delivers it
VCN / vg
Vector Copy Number / viral genomes, the potency and dose units for gene therapy
MOI
Multiplicity of Infection
CDMO / CMO / CRO
Contract Development and Manufacturing, Manufacturing, and Research Organizations
MSAT
Manufacturing Science and Technology, the function that owns the process once it is in the plant
BSE / TSE
Bovine and Transmissible Spongiform Encephalopathy, the basis for animal origin declarations
LIMS
Laboratory Information Management System
MES
Manufacturing Execution System
ERP
Enterprise Resource Planning
SCADA / DCS / PLC
Supervisory Control and Data Acquisition, Distributed Control System, Programmable Logic Controller
EDMS / QMS software
Electronic Document Management System
GAMP 5
Good Automated Manufacturing Practice, the ISPE computerized system validation framework
RBAC
Role Based Access Control
COGS
Cost of Goods Sold
FTO
Freedom To Operate, the patent clearance question
IP
Intellectual Property
NDC
National Drug Code
UDI
Unique Device Identification
DSCSA
Drug Supply Chain Security Act, the US serialization and traceability law
FMD
Falsified Medicines Directive, the EU counterpart
REMS
Risk Evaluation and Mitigation Strategy
RMP
Risk Management Plan, the EU counterpart to a REMS
PSUR / PBRER
Periodic Safety Update Report / Periodic Benefit-Risk Evaluation Report
DSUR
Development Safety Update Report
SUSAR
Suspected Unexpected Serious Adverse Reaction
SAE / AE
Serious Adverse Event / Adverse Event
IRB / IEC
Institutional Review Board / Independent Ethics Committee
CSR
Clinical Study Report
ITT / PP
Intention To Treat / Per Protocol analysis populations
BE / BA
Bioequivalence / Bioavailability
BCS
Biopharmaceutics Classification System, the solubility and permeability grid behind ICH M9 biowaivers
IVIVC
In Vitro In Vivo Correlation
MedDRA
Medical Dictionary for Regulatory Activities
NCE / NME
New Chemical Entity / New Molecular Entity
PoC
Proof of Concept
FIH
First In Human
MTD / MABEL
Maximum Tolerated Dose / Minimum Anticipated Biological Effect Level, the two ways to pick a starting dose
NOAEL
No Observed Adverse Effect Level
HED
Human Equivalent Dose
TTC
Threshold of Toxicological Concern, 1.5 micrograms per day in ICH M7
CMC
Chemistry, Manufacturing, and Controls
ETT / ETP
Emerging Technology Team / Program (FDA), engagement path for novel manufacturing
GMP
Good Manufacturing Practice
IPC
In-Process Control
ITF
Innovation Task Force (EMA)
KMS
Knowledge Management System
MVPC
Multivariate Process Control
PAM
Parameter–Attribute Matrix
PI
Principal Investigator, also the OSIsoft / AVEVA PI System (data historian). Not to be confused with prescribing information, which shares the abbreviation
RCL
Replication-Competent Lentivirus (analogously RCV), a gene-therapy safety attribute
HPLC
High performance liquid chromatography, the workhorse separation behind most assay and impurity methods
UHPLC
Ultra high performance liquid chromatography, sub-2-micron particles at higher pressure for faster, sharper separations
GC
Gas chromatography, the separation of choice for volatiles, including residual solvents under ICH Q3C
UV
Ultraviolet detection, the default LC detector where the analyte has a chromophore
DAD
Diode array detector, UV across a spectrum at once, so peak purity can be assessed as well as area
ELSD
Evaporative light scattering detector: the eluent is nebulized and evaporated and the remaining particles scatter light, so analytes with no chromophore still respond. Near universal, but the response is non-linear
CAD
Charged aerosol detector: like ELSD, the eluent is nebulized, but the dried particles are charged and the charge is measured. More uniform response than ELSD and better at low levels
RID
Refractive index detector, universal but insensitive and intolerant of gradients, still standard for sugars and polymers
FLD
Fluorescence detector, high sensitivity and selectivity where the analyte fluoresces or can be derivatized to
FID
Flame ionization detector, the general purpose GC detector for organic compounds
TCD
Thermal conductivity detector, a universal but insensitive GC detector, used for fixed gases and water
MS
Mass spectrometry, identification and quantitation by mass to charge ratio, and the basis of nitrosamine and genotoxic impurity methods
LC-MS
Liquid chromatography coupled to mass spectrometry
GC-MS
Gas chromatography coupled to mass spectrometry
HRMS
High resolution mass spectrometry, accurate mass sufficient to assign elemental composition
ICP-MS
Inductively coupled plasma mass spectrometry, the reference technique for elemental impurities under ICH Q3D
ICP-OES
Inductively coupled plasma optical emission spectroscopy, the less sensitive alternative to ICP-MS for elemental impurities
AAS
Atomic absorption spectroscopy, the older elemental technique largely displaced by ICP
CE
Capillary electrophoresis, separation by charge to size ratio in a narrow capillary
CE-SDS
Capillary electrophoresis with sodium dodecyl sulfate, the size based purity method for therapeutic proteins
cIEF
Capillary isoelectric focusing, charge variant analysis for proteins
icIEF
Imaged capillary isoelectric focusing, cIEF with whole capillary detection
SEC
Size exclusion chromatography, separation by hydrodynamic size, the standard aggregate method for biologics
IEX
Ion exchange chromatography, separation by charge
AEX
Anion exchange chromatography
CEX
Cation exchange chromatography
MALS
Multi angle light scattering, absolute molar mass without column calibration
SEC-MALS
Size exclusion chromatography with multi angle light scattering detection
SPR
Surface plasmon resonance, label free binding kinetics
BLI
Biolayer interferometry, label free binding kinetics on a fiber optic tip
IR
Infrared spectroscopy. Not to be confused with an agency information request, which shares the abbreviation
FTIR
Fourier transform infrared spectroscopy, standard for identity and for polymorph and excipient work
NIR
Near infrared spectroscopy, widely used at line for blend uniformity and moisture as a process analytical tool
DSC
Differential scanning calorimetry, thermal transitions including glass transition and melting
XRPD
X-ray powder diffraction, the definitive test for crystalline form and for detecting crystallinity in an amorphous dispersion
DVS
Dynamic vapour sorption, moisture uptake against relative humidity
LOD
Limit of detection, the lowest level reliably distinguished from noise
LOQ
Limit of quantitation, the lowest level measurable with acceptable accuracy and precision
RSD
Relative standard deviation, precision expressed as a percentage of the mean
f2
The similarity factor comparing two dissolution profiles; 50 to 100 is conventionally similar
LAL
Limulus amoebocyte lysate, the bacterial endotoxin test reagent
TAMC
Total aerobic microbial count
TYMC
Total combined yeasts and molds count
CFU
Colony forming unit, the microbial count unit
EU
Endotoxin unit, the endotoxin potency unit
MVD
Maximum valid dilution, how far a sample may be diluted and still detect the endotoxin limit
MFT
Media fill test, the same thing by another name
WFI
Water for injection, the highest grade of pharmaceutical water
PW
Purified water
CIP
Clean in place, automated cleaning without disassembly
SIP
Steam in place, in situ steam sterilization of equipment
MOC
Materials of construction, what the product touches and whether it may
FAT
Factory acceptance testing, at the vendor before shipment
SAT
Site acceptance testing, after installation
IQ
Installation qualification, that it was installed as specified
OQ
Operational qualification, that it operates across its range
PQ
Performance qualification, that it performs in routine use with the actual process
CSV
Computer system validation
CSA
Computer software assurance, FDA's risk based successor framing to CSV
GAMP
Good automated manufacturing practice, the ISPE framework for computerized systems
EBR
Electronic batch record
EDMS
Electronic document management system
OOS
Out of specification, a result outside the registered acceptance criteria
OOT
Out of trend, a result within specification but not where the history says it should be
OOE
Out of expectation, an atypical result not yet out of specification
APR
Annual product review, the FDA periodic review under 211.180(e)
PQR
Product quality review, the EU equivalent under EU GMP chapter 1
DMF
Drug master file, confidential manufacturing detail filed with FDA and referenced by a sponsor
ASMF
Active substance master file, the EU counterpart to a type II DMF
GDUFA
Generic Drug User Fee Amendments
BsUFA
Biosimilar User Fee Act
AA
Accelerated approval
ILAP
Innovative Licensing and Access Pathway, the MHRA scheme
PIP
Paediatric investigation plan, required in the EU
SPA
Special protocol assessment
NCE
New chemical entity
NME
New molecular entity
INN
International nonproprietary name, the generic name assigned by WHO
USAN
United States adopted name
UNII
Unique ingredient identifier, the FDA substance code
PLI
Pre-license inspection, the biologics equivalent ahead of a BLA license
NAI
No action indicated, the cleanest FDA inspection classification
VAI
Voluntary action indicated, findings that do not warrant regulatory action
OAI
Official action indicated, the classification that can block an approval
PDE
Permitted daily exposure, the daily dose considered without appreciable risk, used for solvents, elemental impurities and cleaning limits
ADE
Acceptable daily exposure, the same concept under a different name, common in cleaning validation
OEL
Occupational exposure limit, what the operator may breathe
OEB
Occupational exposure band, the containment category an OEL falls into
MABEL
Minimum anticipated biological effect level, used to set a first in human dose for biologics
NDSRI
Nitrosamine drug substance related impurity, a nitrosamine formed from the API's own amine, and the hardest class to control
NDMA
N-nitrosodimethylamine, the nitrosamine behind the sartan and ranitidine recalls
PK
Pharmacokinetics, what the body does to the drug
PD
Pharmacodynamics, what the drug does to the body. Not to be confused with a protocol deviation, which shares the abbreviation
ADME
Absorption, distribution, metabolism and excretion
BDDCS
Biopharmaceutics drug disposition classification system, solubility against metabolism
BE
Bioequivalence
Cmax
The maximum plasma concentration reached
Tmax
The time at which Cmax occurs
ASD
Amorphous solid dispersion, the drug held amorphous in a polymer so it dissolves
HME
Hot melt extrusion, one route to an amorphous solid dispersion
SDD
Spray dried dispersion, the other common route
MDI
Metered dose inhaler
pMDI
Pressurized metered dose inhaler
DPI
Dry powder inhaler
APSD
Aerodynamic particle size distribution, the property that decides where an inhaled dose lands
NGI
Next generation impactor, the standard cascade impactor for APSD
MMAD
Mass median aerodynamic diameter
GSD
Geometric standard deviation, the spread of an aerodynamic distribution
DDU
Delivered dose uniformity, for inhalation products
CU
Content uniformity
AV
Acceptance value, the statistic behind USP <905> uniformity of dosage units
mAb
Monoclonal antibody
bsAb
Bispecific antibody
Fab
The antigen binding fragment of an antibody
Fc
The crystallisable fragment of an antibody, which carries effector function and half life
scFv
Single chain variable fragment
DAR
Drug to antibody ratio, the average payload loading on an antibody drug conjugate and one of its critical quality attributes
HCP
Host cell protein, the process related impurity that has to be cleared and measured
HCD
Host cell DNA, cleared and limited for the same reason
ProA
Protein A chromatography, the capture step for most antibodies
MCB
Master cell bank
WCB
Working cell bank
EOPC
End of production cells, tested to show the bank held across the campaign
HEK
Human embryonic kidney cells, common for transient expression and viral vector production
VCD
Viable cell density
PDL
Population doubling level, how far a cell line has been pushed from its bank
AAV
Adeno-associated virus, the dominant in vivo gene therapy vector
LV
Lentiviral vector, the usual vector for ex vivo cell modification
LNP
Lipid nanoparticle, the delivery system behind mRNA products
pDNA
Plasmid DNA, the starting material for most vector and mRNA processes
VLP
Virus like particle
CAR
Chimeric antigen receptor
TCR
T cell receptor
iPSC
Induced pluripotent stem cell
MSC
Mesenchymal stromal cell
HSC
Haematopoietic stem cell
BSE
Bovine spongiform encephalopathy, the reason animal origin materials carry a sourcing statement
TSE
Transmissible spongiform encephalopathy, the wider family BSE belongs to
MDR
Medical Device Regulation, EU 2017/745
IVDR
In Vitro Diagnostic Regulation, EU 2017/746
DHF
Design history file, the record of how a device design was developed
DMR
Device master record, the specification of how it is built
DHR
Device history record, the record of what was actually built
510(k)
The FDA premarket notification route based on substantial equivalence to a predicate
PMA
Premarket approval, the FDA route for the highest risk devices
HDE
Humanitarian device exemption
EUA
Emergency use authorization
OPV
Ongoing process verification, the EU term for the same activity
SUPAC
Scale-up and post-approval changes, the FDA guidance family for what a change requires
RS
Reference standard
WRS
Working reference standard, qualified against the primary
RLD
Reference listed drug, the innovator product a generic is compared against
RRT
Relative retention time, where an impurity elutes against the main peak
RRF
Relative response factor, how strongly an impurity responds against the main peak
NLT
Not less than
NMT
Not more than
CMO
Contract manufacturing organization
CDMO
Contract development and manufacturing organization
CRO
Contract research organization
CTO
Contract testing organization
SOW
Statement of work
QAG
Quality agreement, which defines who is responsible for what between a sponsor and its manufacturer
PIC
Person in plant, your own person standing on the contractor's floor
S&OP
Sales and operations planning, the cadence that reconciles demand with what the plant can make
MRP
Material requirements planning. Not to be confused with the EU mutual recognition procedure, which shares the abbreviation
BOM
Bill of materials
MOQ
Minimum order quantity, often the real constraint on a clinical campaign
OTIF
On time in full, the service measure a supply chain is judged on
EPCIS
Electronic product code information services, the data standard serialization events are exchanged in
Ph. Eur.
European Pharmacopoeia, the compendial standard across the EU and beyond
ChP
Chinese Pharmacopoeia
NF
National Formulary, published with the USP and covering excipients
OPQ
Office of Pharmaceutical Quality, the CDER office that reviews CMC
ORA
Office of Regulatory Affairs, FDA's field and inspection arm
COFEPRIS
Comisión Federal para la Protección contra Riesgos Sanitarios, the Mexican health regulator
Swissmedic
The Swiss agency for therapeutic products
ASTM
ASTM International, which publishes consensus standards including E2500 for equipment qualification
IEC
International Electrotechnical Commission
ClinOps
Clinical Operations, the function that actually runs the trial: sites, monitors, supply, data and timelines
CRA
Clinical Research Associate, the monitor who visits sites and verifies what was recorded against what happened
CRC
Clinical Research Coordinator, the site-side counterpart to the CRA
DBL
Database Lock, the point at which the clinical database is frozen and no further changes are made without a documented reason. Everything downstream, unblinding, analysis and the study report, dates from it
SDBL
Soft Database Lock, a provisional freeze to allow cleaning checks before the hard lock
CDM
Clinical Data Management, the function responsible for the database from design to lock
DM
Data Management, used interchangeably with CDM
EDC
Electronic Data Capture, the system sites enter clinical data into
CRF
Case Report Form, the instrument that defines what data the protocol collects
eCRF
Electronic Case Report Form
SDV
Source Data Verification, checking entered data against the source record
SDR
Source Data Review, looking at the source for quality signals rather than field-by-field checking
CDISC
Clinical Data Interchange Standards Consortium, which publishes the data standards regulators expect
SDTM
Study Data Tabulation Model, the CDISC standard for submitted raw clinical data
ADaM
Analysis Data Model, the CDISC standard for analysis-ready datasets
TMF
Trial Master File, the record that demonstrates the trial was conducted to GCP
eTMF
Electronic Trial Master File
CTMS
Clinical Trial Management System, where enrolment, visits, payments and site status are tracked
IWRS
Interactive Web Response System, which handles randomization and drug assignment
IRT
Interactive Response Technology, the current term for IWRS and IVRS together
RTSM
Randomization and Trial Supply Management, the same system viewed from the supply side
IMP
Investigational Medicinal Product, the EU term for the product under study
NIMP
Non-Investigational Medicinal Product, comparators and background therapy supplied but not under study
DMC
Data Monitoring Committee, independent of the sponsor, which reviews unblinded safety data
DSMB
Data and Safety Monitoring Board, the same body under the more common US name
IDMC
Independent Data Monitoring Committee
CEC
Clinical Events Committee, which adjudicates endpoints blind to treatment
RBM
Risk-Based Monitoring, monitoring effort directed by risk rather than spread evenly
RBQM
Risk-Based Quality Management, the wider ICH E6(R3) framing that RBM sits inside
KRI
Key Risk Indicator, the site-level metric that triggers a closer look
QTL
Quality Tolerance Limit, the study-level threshold whose breach has to be reported in the study report
ICF
Informed Consent Form
IB
Investigator's Brochure, the document that tells the investigator what is known about the product
SAP
Statistical Analysis Plan, finalized before unblinding or it is not a plan
SIV
Site Initiation Visit
PSV
Pre-Study Visit, also called a site qualification visit
COV
Close-Out Visit
FPI
First Patient In
LPI
Last Patient In
LPO
Last Patient Out
FPFV
First Patient First Visit
LPLV
Last Patient Last Visit, the milestone database lock is planned from
PD (clinical)
Protocol Deviation, a departure from the protocol. Not to be confused with pharmacodynamics, which shares the abbreviation
mITT
Modified Intention to Treat, the ITT population after a prespecified exclusion
LOCF
Last Observation Carried Forward, an imputation method now largely displaced by mixed models
MMRM
Mixed Model for Repeated Measures, the usual handling of longitudinal data with dropout
BOCF
Baseline Observation Carried Forward
SF
Screen Failure, a consented subject who does not meet eligibility
SoC
Standard of Care, the comparator a trial usually has to beat or match
ORR
Overall Response Rate
PFS
Progression-Free Survival
OS
Overall Survival
DoR
Duration of Response
TTE
Time to Event, the family of endpoints PFS and OS belong to
NNT
Number Needed to Treat
MoA
Mechanism of Action
PV (safety)
Pharmacovigilance, the collection and assessment of safety data across a product's life. Not to be confused with process validation, which shares the abbreviation
QPPV
Qualified Person for Pharmacovigilance, the named individual legally answerable for the EU safety system
PSMF
Pharmacovigilance System Master File, the document that describes that system
ICSR
Individual Case Safety Report, one adverse event report
E2B
The ICH standard for transmitting ICSRs electronically
EudraVigilance
The EU database of suspected adverse reactions
FAERS
FDA Adverse Event Reporting System
VAERS
Vaccine Adverse Event Reporting System
ADR
Adverse Drug Reaction, an adverse event with at least a reasonable possibility of causal relationship
AESI
Adverse Event of Special Interest, prespecified and followed closely
TEAE
Treatment-Emergent Adverse Event
PRAC
Pharmacovigilance Risk Assessment Committee, the EMA committee that owns safety
PASS
Post-Authorisation Safety Study
PAES
Post-Authorisation Efficacy Study
aRMM
Additional Risk Minimisation Measure, what a risk management plan commits to beyond labelling
SmPC
Summary of Product Characteristics, the EU product information
PIL
Patient Information Leaflet
DHPC
Direct Healthcare Professional Communication, the letter that goes out when something has to be said quickly
BRA
Benefit-Risk Assessment
RA
Regulatory Affairs, the function that owns the relationship with the agency and the content of what is filed
MAH
Marketing Authorisation Holder, the legal entity answerable for the product in the EU
RFI
Request for Information, an agency question during review
IR (regulatory)
Information Request, an FDA question during review. Not to be confused with infrared spectroscopy, which shares the abbreviation
CR
Complete Response, the sponsor's answer to a CRL
Type A meeting
An FDA meeting to resolve a stalled development programme, scheduled within 30 days
Type B meeting
An FDA milestone meeting: pre-IND, end of Phase 2, pre-NDA or pre-BLA
Type C meeting
Any other FDA meeting about a development programme
Type D meeting
A narrow FDA meeting on a focused issue, introduced under PDUFA VII
pre-IND
The meeting that agrees what the IND has to contain before it is written
RTOR
Real-Time Oncology Review, rolling review of an oncology application
AdCom
Advisory Committee, the public meeting at which outside experts advise FDA
505(b)(2)
The NDA pathway that relies in part on data the applicant does not own
MRP (regulatory)
Mutual Recognition Procedure, the EU route based on an existing national authorisation. Not to be confused with material requirements planning, which shares the abbreviation
DCP
Decentralised Procedure, the EU route for a product not yet authorised anywhere
RMS
Reference Member State, the country that leads an MRP or DCP
CMS
Concerned Member State, the countries that follow it
Variation Type IA
A minor EU change notified after implementation
Variation Type IB
A minor EU change notified before implementation
Variation Type II
A major EU change requiring approval before implementation
NDA (agreement)
Non-Disclosure Agreement. Not to be confused with a New Drug Application, which shares the abbreviation
CDA
Confidential Disclosure Agreement, the same thing under another name
SPC (regulatory)
Supplementary Protection Certificate, which extends patent term in the EU. Not to be confused with statistical process control, which shares the abbreviation
PI (labelling)
Prescribing Information, the US label. Not to be confused with a principal investigator, which shares the abbreviation
USPI
United States Prescribing Information
PLR
Physician Labeling Rule, the format US prescribing information has to follow
SUPAC-IR
Scale-up and post-approval changes for immediate release oral solids
SUPAC-MR
Scale-up and post-approval changes for modified release oral solids
HEOR
Health Economics and Outcomes Research
HTA
Health Technology Assessment, the process that decides whether a payer will fund a product
NICE
National Institute for Health and Care Excellence, the English HTA body
ICER
Incremental Cost-Effectiveness Ratio, and also the US Institute for Clinical and Economic Review
QALY
Quality-Adjusted Life Year, the unit most cost-effectiveness arguments are made in
P&R
Pricing and Reimbursement
GTN
Gross to Net, the difference between list price and what is actually collected
WAC
Wholesale Acquisition Cost, the US list price
ASP
Average Sales Price
AMP
Average Manufacturer Price
340B
The US programme requiring discounts to certain safety-net providers
PBM
Pharmacy Benefit Manager
GPO
Group Purchasing Organization
IDN
Integrated Delivery Network
LOE
Loss of Exclusivity, the cliff a lifecycle plan is written against
KOL
Key Opinion Leader
MSL
Medical Science Liaison
DTC
Direct to Consumer
PMO
Programme Management Office
RACI
Responsible, Accountable, Consulted, Informed, the matrix that settles who decides
WBS
Work Breakdown Structure
KPI
Key Performance Indicator
OKR
Objectives and Key Results
SLA
Service Level Agreement
RFP
Request for Proposal
RFQ
Request for Quotation
MSA (contract)
Master Services Agreement, the umbrella contract a statement of work sits under. Not to be confused with measurement system analysis, which shares the abbreviation
LOI
Letter of Intent
BD
Business Development
NPV
Net Present Value
IRR
Internal Rate of Return
CAGR
Compound Annual Growth Rate
EBITDA
Earnings Before Interest, Taxes, Depreciation and Amortization
CapEx
Capital Expenditure, the plant and equipment side of a budget
OpEx
Operating Expenditure
FTE
Full-Time Equivalent, the unit a resource model is built in
COGM
Cost of Goods Manufactured
RFT
Right First Time, the quality metric that decides how much rework a site is carrying
OEE
Overall Equipment Effectiveness
MTBF
Mean Time Between Failures
MTTR
Mean Time to Repair
SKU
Stock Keeping Unit
LT
Lead Time
DSI
Days of Supply Inventory
ANOVA
Analysis of Variance
CI
Confidence Interval
CV
Coefficient of Variation
LSM
Least Squares Mean
NCA
Non-Compartmental Analysis, the standard first pass at pharmacokinetic data
popPK
Population Pharmacokinetics
PBPK
Physiologically Based Pharmacokinetic modelling
QTc
Corrected QT interval, the cardiac safety measure behind ICH E14
ROC
Receiver Operating Characteristic, the curve behind a diagnostic cut-off
TOST
Two One-Sided Tests, the equivalence test behind bioequivalence
MCID
Minimal Clinically Important Difference
SD
Standard Deviation
SEM
Standard Error of the Mean
ML
Machine Learning
AI/ML
Artificial Intelligence and Machine Learning, and the regulatory frameworks now attaching to both
GDocP
Good Documentation Practice, the habits that make a record defensible
GCDMP
Good Clinical Data Management Practice
GRP
Good Review Practice
QbR
Question-Based Review, the FDA generic review framework
APQR
Annual Product Quality Review, the term used where APR and PQR are treated as one
SQA
Supplier Quality Assurance
PQA
Product Quality Attribute
TSE/BSE
Transmissible and bovine spongiform encephalopathy, the sourcing statement animal derived materials carry
DI (data)
Data Integrity
AT
Audit Trail, and the requirement to review it rather than merely enable it
ATR
Audit Trail Review
CoI
Chain of Identity, the unbroken link between a patient, their starting material and the dose that comes back. Lose it on an autologous product and the lot is not releasable at any level of potency
CoC (custody)
Chain of Custody, the documented handling of that material at every transfer. Not to be confused with a certificate of conformance, which shares the abbreviation
MAM
Multi-Attribute Method, a single LC-MS method that monitors many product quality attributes at once and can replace several conventional assays
PUPSIT
Pre-Use Post-Sterilization Integrity Test, testing the sterilizing filter after sterilization but before use. Annex 1 expects it or a justified alternative
ADCC
Antibody-Dependent Cellular Cytotoxicity, an antibody effector function and often a potency assay
CDC (assay)
Complement-Dependent Cytotoxicity, the other antibody effector function. Not to be confused with the Centers for Disease Control and Prevention
PTM
Post-Translational Modification, glycosylation, oxidation, deamidation and the rest of what makes a protein heterogeneous
HMW / LMW
High and low molecular weight species, aggregate and fragment, measured by size exclusion chromatography
RCR
Replication Competent Retrovirus, tested for in retroviral and lentiviral vector products
TVD
Total Viable Dose, the cell count actually administered
GTMP
Gene Therapy Medicinal Product, an ATMP subclass
CBMP
Cell-Based Medicinal Product
Grade A / B / C / D
The EU GMP cleanroom grades: A is the critical zone, B its background, C and D the supporting areas
UDAF
Unidirectional Airflow, what used to be called laminar flow
LAF
Laminar Airflow, the older term for the same thing
ACH
Air Changes per Hour, the recovery argument for a classified room
dP
Differential Pressure, the cascade that keeps a clean room clean
AHU
Air Handling Unit
P&ID
Piping and Instrumentation Diagram, the drawing qualification is written against
PFD
Process Flow Diagram
CQV
Commissioning, Qualification and Validation
GEP
Good Engineering Practice, the work that makes qualification short
FDS
Functional Design Specification
BSL
Biosafety Level, 1 through 4
BSC
Biological Safety Cabinet
MLT
Microbial Limits Test
AET
Analytical Evaluation Threshold, the level above which a leachable has to be identified
PET (preservative)
Preservative Efficacy Test, USP <51>. Not to be confused with positron emission tomography
HAZOP
Hazard and Operability Study
LOPA
Layer of Protection Analysis
SIL
Safety Integrity Level
ALARP
As Low As Reasonably Practicable
ATEX
The EU directives on equipment for explosive atmospheres, which solvent handling runs into
COSHH
Control of Substances Hazardous to Health, the UK regulations
SDS (safety)
Safety Data Sheet. Not to be confused with sodium dodecyl sulfate, which shares the abbreviation
DMAIC
Define, Measure, Analyze, Improve, Control, the Six Sigma improvement cycle
5 Why
Asking why until the answer stops being a symptom, the simplest root cause tool and the easiest to stop too early
8D
Eight Disciplines, a structured problem-solving and corrective action format
A3
A one-page problem statement, analysis and countermeasure, named for the paper size
SIPOC
Suppliers, Inputs, Process, Outputs, Customers, a scoping map
VOC
Voice of the Customer, and in an EHS context volatile organic compound
VSM
Value Stream Mapping
SMED
Single-Minute Exchange of Die, the changeover reduction method behind campaign planning
TPM
Total Productive Maintenance
5S
Sort, set in order, shine, standardize, sustain
Kaizen
Continuous improvement, and the short focused event named after it
Gemba
The place the work happens, and the walk you take to see it
Poka-yoke
Mistake-proofing: designing the error out rather than training against it
GRR
Gauge Repeatability and Reproducibility, the measurement half of process variation
eQMS
Electronic Quality Management System
KPP
Key Process Parameter, important but not critical to a quality attribute
IFU
Instructions for Use
HF
Human Factors, the discipline behind whether a patient can actually use the device
URRA
Use-Related Risk Analysis, the human factors counterpart to an FMEA
IDE
Investigational Device Exemption, the device counterpart to an IND
QSR
Quality System Regulation, 21 CFR 820
QMSR
Quality Management System Regulation, the FDA rule aligning 21 CFR 820 with ISO 13485
MDSAP
Medical Device Single Audit Program, one audit accepted by several regulators
NB
Notified Body, which certifies devices for the EU market
CE Mark
The mark showing a device meets EU requirements
UKCA
UK Conformity Assessed, the post-Brexit equivalent
EUDAMED
The EU database for medical devices
PMS
Post-Market Surveillance
PMCF
Post-Market Clinical Follow-up
MDD
Medical Device Directive, superseded by the MDR
IDMP
Identification of Medicinal Products, the ISO standards for describing a product in data rather than prose
xEVMPD
Extended EudraVigilance Medicinal Product Dictionary, where EU products are registered
SPOR
Substances, Products, Organisations and Referentials, the EMA master data services behind IDMP
NBE
New Biological Entity
XDC
The wider conjugate family beyond antibodies: peptide, small molecule and radio conjugates
PROTAC
Proteolysis Targeting Chimera, a bifunctional degrader
siRNA
Small Interfering RNA
ASO
Antisense Oligonucleotide
SEDDS
Self-Emulsifying Drug Delivery System
SMEDDS
Self-Microemulsifying Drug Delivery System
PLGA
Poly(lactic-co-glycolic acid), the usual polymer for long-acting injectables
PEG
Polyethylene glycol, and PEGylation as a half-life strategy
3PL
Third-Party Logistics provider
LSP
Logistics Service Provider
How to read this, and what it is not. the limits, stated once

This is a map, not the territory. Every entry is a one-line orientation written to get you to the right document quickly, and not one of them is a substitute for the document itself. Guidelines are revised, revision designators move, and a summary that was accurate when it was written can quietly stop being accurate. Confirm against the current official text before you act on any of it, and treat the links as the authority rather than the summaries.

Where a stable deep link to an individual document exists it is used, which is mostly true of the electronic Code of Federal Regulations. Where it does not, the link goes to the index published by the body that owns the document: ICH by guideline family, EudraLex for the EU GMP annexes, USP and PDA to their own catalogs. Several of those catalogs are behind a paywall, which is a fact about the industry rather than about this page.

Coverage is deliberately uneven, because use is uneven. ICH quality guidelines are complete. The safety, efficacy and multidisciplinary series are here in full but summarized more briefly. Of 21 CFR only the parts that come up in a CMC or quality conversation are included, with the handful of Part 211 sections that get cited by number called out separately. The PDA technical reports are a selection of the most referenced, not the full catalog of ninety or so.

Where one abbreviation means two different things, both are here and each says so. TGA is either the Australian regulator or thermogravimetric analysis. USP is either the pharmacopoeia or upstream processing. Hiding one of those to keep a list tidy would defeat the point of the list.

This replaces the two smaller widgets that used to sit on the writing index, the ICH quick reference and the CMC glossary. Everything that was in either is in here.