| Abbreviation | Definition |
|---|
| A | |
| ABPI | Association of the British Pharmaceutical Industry |
| AIM | Active Ingredient Manufacturer (Europe) |
| ANDA | Abbreviated New Drug Application (USA) |
| API | Active Pharmaceutical Ingredient (USA) |
| ASEAN | Association of South East Asian Nations |
| ASTM | American Society for Testing and Materials |
| B | |
| BNF | British National Formulary |
| BP | British Pharmacopoeia |
| BPC | Bulk Pharmaceutical Chemical |
| BPE | Bulk Pharmaceutical Excipient |
| BSE | Bovine Spongiform Encephalopathy |
| BSI | British Standards Institute |
| C | |
| CAS | Chemical Abstracts System |
| CBER | Centre for Biologics Evaluation & Research (FDA) |
| CD | Controlled Drugs |
| CDER | Centre for Drug Evaluation & Research (FDA) |
| CE | Capillary Electrophoresis |
| CE | Conformiteé European (British Kitemark) (EU) |
| CEP | Certificate of the European Pharmacopoeia (See C of S) |
| CFR | Code of Federal Regulations (USA) |
| CFU | Colony Forming Unit |
| CIP | Clean In Place |
| CMO | Contract Manufacturing Organisation |
| cGMP | Current Good Manufacturing Practice |
| C of A | Certificate Of Analysis |
| C of C | Certificate Of Conformance |
| C of S | Certificate Of Suitability (EU; See CEP) |
| COPD | Chronic Obstructive Pulmonary Disease |
| COSHH | Control Of Substances Hazardous to Health |
| CPMP | Committee for Proprietary Medicinal Products (EU) |
| CRO | Contract Research Organisation |
| CSV | Computer System Validation |
| CT | Clinical Trials |
| CTA | Clinical Trials Application |
| CTD | Common Technical Document |
| CTM | Clinical Trial Material |
| D | |
| DQ | Design Qualification (Validation - See IQ, OQ & PQ) |
| DMF | Drug Master File |
| E | |
| EDMF | European Drug Master File |
| EDQM | European Department for the Quality of Medicines |
| EEC | European Economic Community |
| EIR | Establishment Inspection Report (written by FDA inspector, USA) |
| EMEA | European Medicines Evaluation Agency |
| EU | European Union |
| EUGMP | European Union Good Manufacturing Practice |
| F | |
| FDA | Food and Drug Administration (USA) |
| FOI | Freedom Of Information (Act) (USA) |
| G | |
| GAMP | Good Automated Manufacturing Practice |
| GCLP | Good Control Laboratory Practice |
| GCP | Good Clinical Practice |
| GDP | Good Documentation Practice |
| GC | Gas Chromatography |
| GLP | Good Laboratory Practice |
| GMO | Genetically Modified Organism |
| GMP | Good Manufacturing Practice (See cGMP) |
| H | |
| HEPA | High Efficiency Particulate Air (Filter) |
| HPLC | High Performance Liquid Chromatography |
| HSE | Health and Safety Executive |
| HVAC | Heating, Ventilation and Air Conditioning |
| I | |
| ICH | International Conference on Harmonisation |
| IMP | Investigational Medicinal Product ( Licence) |
| IMPD | Investigational Medicinal Product Dossier |
| IND | Investigational New Drug (USA) |
| IPC | In Process Control |
| IQ | Installation Qualification (Validation - See DQ, OQ & PQ) |
| ISO | International Standards Organisation |
| J | |
| JP | Japanese Pharmacopoeia |
| L | |
| LIMS | Laboratory Information Management System |
| LOD | Loss On Drying |
| M | |
| MAA | Marketing Authorisation Application (Europe & ROW) |
| MDI | Metered Dose Inhaler |
| DPI | Dose Powder Inhaler |
| MHRA | Medicines and Healthcare Regulatory Agency (UK) |
| MHW | Ministry of Health and Welfare (Japan) |
| ML | Manufacturer's Licence |
| MRA | Mutual Recognition Agreement (Global cGMP auditing scheme) |
| MS | Mass Spectrometry |
| N | |
| NCE | New Chemical Entity |
| NDA | New Drug Application (USA) |
| NDS | New Drug Submission (Canada) |
| NGT | Not Greater Than |
| NICE | National Institute for Clinical Excellence (UK) |
| NIR | Near Infra Red |
| NLT | Not Less Than |
| NMR | Nuclear Magnetic Resonance (Spectrometry) |
| NMT | Not More Than |
| O | |
| OOS | Out Of Specification (result) |
| OPA | Orientated PolyAmide |
| OQ | Operational Qualification (Validation - See DQ, IQ, & PQ) |
| OTC | Over The Counter (medicine) |
| OVI | Organic Volatile Impurities |
| P | |
| PAI | Pre Approval Inspection (USA) |
| Ph.Eur | European Pharmacopoeia |
| PIL | Product Information Leaflet |
| PL | Product Licence |
| POM | Prescription Only Medicine |
| PQ | Performance Qualification (Validation - See DQ, IQ, & OQ) |
| PV | Process Validation |
| Q | |
| QA | Quality Assurance |
| QC | Quality Control |
| QP | Qualified Person (Europe) |
| R | |
| RH | Relative Humidity |
| ROI | Residue On Ignition |
| RSD | Relative Standard Deviation |
| S | |
| SNDA | Supplemental New Drug Application (USA) |
| SOP | Standard Operating Procedure |
| SPC or SmPC | Summary of Product Characteristics (Europe) |
| SST | System Suitability Test |
| T | |
| TLC | Thin Layer Chromatography |
| TSE | Transmissible Spongiform Encephalopathy |
| U | |
| USNF | United States National Formulary (USA) |
| USP | United States Pharmacopoeia (USA) |
| V | |
| VMP | Validation Master Plan |
| VSR | Validation Summary Report |
| W | |
| WFI | Water For Injection |
| WHO | World Health Organisation |
