| ACU | Air Cooling Unit |
| ADE | Adverse Drug Event |
| AHU | Air Handling Unit |
| ANDA | Abbreviated New Drug Application |
| ANVISA | Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency, Brazil) |
| API | Active Pharmaceutical Ingredient |
| APQR | Annual Product Quality Review |
| AQL | Acceptable Quality Level |
| ASM | Active Substance Manufacturer |
| ASMF | Active Substance Master File |
| AST | Accelerated Stability Testing |
| ASTM | American Society for Testing and Materials |
| BA | Bioavailability |
| BE | Bioequivalence |
| BET | Bacterial Endotoxin Test |
| BMR | Batch Manufacturing Record |
| BOD | Biological Oxygen Demand |
| BOM | Bill of Materials |
| BOPP | Biaxially Oriented Polypropylene |
| BP | British Pharmacopoeia |
| BPR | Batch Packaging Record |
| BSE | Bovine Spongiform Encephalopathy (Mad Cow Disease) |
| BSR | Bounded Store Room |
| CAPA | Corrective and Preventive Action |
| CBE | Changes Being Effected |
| CBER | Center for Biologics Evaluation and Research (FDA) |
| CCIT | Container Closure Integrity Test |
| CDER | Center for Drug Evaluation and Research (FDA) |
| CDSCO | Central Drugs Standard Control Organization (India) |
| CEP | Certification of the Suitability of European Pharmacopoeia Monograph |
| CFR | Code of Federal Regulations |
| CFU | Colony Forming Unit |
| CIP | Clean in Place |
| CMS | Continuous Monitoring System |
| COA | Certificate of Analysis |
| COPP | Certificate of Pharmaceutical Products |
| COS | Certificate of Suitability |
| CPP | Critical Process Parameter |
| CQA | Critical Quality Attribute |
| CRT | Controlled Room Temperature |
| cGMP | Current Good Manufacturing Practices |
| CVP | Cleaning Validation Protocol |
| CVR | Cleaning Validation Report |
| DMF | Drug Master File |
| DOP | Dioctyl Phthalate |
| DQ | Design Qualification |
| EDMF | European Drug Master File |
| EDQM | European Directorate for the Quality of Medicines |
| EH&S | Environmental Health and Safety |
| EIR | Establishment Inspection Report (FDA) |
| EMEA | European Medicines Agency |
| EP | European Pharmacopoeia |
| ETP | Effluent Treatment Plant |
| EU | Endotoxin Unit |
| EU | European Union |
| FAT | Factory Acceptance Testing |
| FBD | Fluid-bed Dryer |
| FBP | Fluid-bed Processor |
| FDC | Fixed-Dose Combination |
| FDA | Food and Drug Administration (United States) |
| FEFO | First Expiry, First Out |
| FG | Finished Goods |
| FGS | Finished Goods Store |
| FIFO | First In, First Out |
| FMEA | Failure Modes and Effects Analysis |
| FOI | Freedom of Information |
| GAMP | Good Automated Manufacturing Practice |
| GC | Gas Chromatography |
| GCLP | Good Clinical Laboratory Practice |
| GCP | Good Clinical Practice |
| GDP | Good Distribution Practice |
| GEP | Good Engineering Practice |
| GIT | Gastrointestinal Tract |
| GLP | Good Laboratory Practice |
| GMO | Genetically Modified Organism |
| GMP | Good Manufacturing Practice |
| GPT | Growth Promotion Test |
| GRAS/E | Generally Recognized as Safe and Effective |
| GRP | Good Review Practice |
| HACCP | Hazard Analysis Critical Control Point |
| HDPE | High-Density Polyethylene |
| HEPA | High-Efficiency Particulate Air (Filter) |
| HPLC | High-Performance Liquid Chromatography |
| HSA | Health Sciences Authority (Singapore) |
| HVAC | Heating, Ventilating and Air Conditioning |
| ICH | International Conference on Harmonisation |
| IH | In House |
| IM | Intramuscular |
| IND | Investigational New Drug |
| INDA | Investigational New Drug Application |
| IP | Indian Pharmacopoeia |
| IPA | Isopropyl Alcohol |
| IPQA | In Process Quality Assurance |
| IPS | In-Process Control |
| IQ | Installation Qualification |
| IR | Immediate Release |
| ISO | International Organization for Standardization |
| ISPE | International Society for Pharmaceutical Engineering |
| IV | Intravenous |
| JP | Japanese Pharmacopoeia |
| KOS | Knowledge Organization System |
| LAF | Laminar Airflow |
| LAL | Limulus Amoebocyte Lysate |
| LCL | Lower Control Limit |
| LD | Lethal Dose |
| LD₅₀ | Lethal Dose Where 50% of the Animal Population Dies |
| LDPE | Low-Density Polyethylene |
| LIMS | Laboratory Information Management System |
| LIR | Laboratory Investigation Report |
| LLC | Line Clearance |
| LOD | Loss on Drying |
| LOD | Limit of Detection |
| LOQ | Limit of Quantification |
| LR | Laboratory Reagent |
| LVPs | Large Volume Parenterals |
| MA | Marketing Authorisation |
| MAA | Marketing Authorisation Application |
| MAC | Maximum Allowable Carryover |
| MACO | Maximum Allowable Carryover |
| MCC | Medicines Control Council (South Africa) |
| MDD | Maximum Daily Dose |
| MEDSAFE | Medicines & Medical Devices Safety Authority (New Zealand) |
| MFR | Master Formula Record |
| MHRA | Medicines and Healthcare Products Regulatory Agency (UK) |
| MOA | Method of Analysis |
| MQRM | Monthly Quality Review Meeting |
| MSDS | Material Safety Data Sheets |
| NCE | New Chemical Entity |
| NDA | New Drug Application |
| NF | National Formulary |
| NIR | Near Infra-Red Spectroscopy |
| NON | Notice of Non-Compliance (Canada) |
| ODI | Orally Disintegrating Tablet |
| OOS | Out of Specification |
| OOT | Out of Trend |
| OQ | Operational Qualification |
| OSD | Oral Solid Dosage |
| OSHA | Occupational Safety and Health Administration |
| OTC | Over-the-Counter |
| PAC | Post-Approval Changes |
| PAO | Poly Alpha Olefin |
| PAT | Process Analytical Technology |
| PDE | Permitted Daily Dosage Exposure |
| PET | Preservative Efficacy Test |
| PLC | Programmable Logical Controller |
| PM | Packing Material |
| PQ | Performance Qualification |
| PVC | Polyvinyl Chloride |
| PVDC | Polyvinylidene Chloride |
| PVP | Process Validation Protocol |
| PVR | Process Validation Report |
| PW | Purified Water |
| QbD | Quality by Design |
| QM | Quality Manual |
| QMS | Quality Management System |
| QRM | Quality Risk Management |
| RCA | Root Cause Analysis |
| RH | Relative Humidity |
| RLAF | Reverse Laminar Airflow |
| RLD | Reference Listed Drug |
| RM | Raw Material |
| RM | Packing Material (as listed in the source, though this is commonly abbreviated as PM) |
| RMG | Rapid Mixer Granulator |
| RO | Reverse Osmosis |
| RS | Related Substance |
| SAT | Site Acceptance Test / Testing |
| SIP | Sterilization in Place |
| SIP | Steam in Place |
| SLS | Sodium Lauryl Sulphate |
| SMF | Site Master File |
| SOP | Standard Operating Procedure |
| SPE | Society for Pharmaceutical Engineering |
| SUPAC | Scale-Up and Post-Approval Changes |
| SVP | Small Volume Parenteral |
| TDS | Total Dissolved Solids |
| TGA | Therapeutic Goods Administration (Australia) |
| TOC | Total Organic Carbon |
| TRF | Test Request Form |
| TSE | Transmissible Spongiform Encephalopathy |
| UCL | Upper Control Limit |
| URS | User Requirement Specification |
| USFDA | United States Food and Drugs Administration |
| USP | United States Pharmacopeia |
| USP-NF | United States Pharmacopeia–National Formulary |
| VMP | Validation Master Plan |
| WFI | Water for Injection |
| WHO | World Health Organization |
| WL | Warning Letter |
