| PVP : Process Validation Protocol |
| PVR : Process Validation Report |
| CVP : Cleaning Validation Protocol |
| CVR : Cleaning Validation Report |
| MQRM : Monthly Quality Review Meeting |
| QRM : Quality Risk Management |
| UCL : Upper control Limit |
| LCL : Lower control Limit |
| IPQA : In process Quality Assurance |
| LLC : Live line clearance |
| 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 |
| CRT : Controlled Room Temperature |
| 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) |
| CAPA: Corrective and preventive action |
| FMEA : Failure mode & Effect Analysis |
| RCA : Root cause Analysis |
| 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 drug standard control organization (India) |
| CEP:Certification of suitability of European Pharmacopoeia monograph |
| GC : Gas Chromatography |
| HSA: Health Sciences Authority, Singapore |
| ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil |
| TGA: Therapeutics goods administration (Australia) |
| USFDA: United states foods and drugs administration |
| FDA: Food and Drug Administration, United States |
| WHO: World Health Organisation |
| JP: Japanese Pharmacopoeia |
| MHRA: Medicines and Healthcare products Regulatory Agency (UK) |
| MEDSAFE: Medicines & medicinal devices safety authority (New zealand) |
| CQA: Critical Quality Attribute |
| MACO : Maximum allowable Carry over |
| ADE: Adverse drug event |
| PDE : Permitted Daily Dosage Exposure |
| ACU: Air Cooling Unit |
| AHU: Air Handling Unit |
| ANDA: Abbreviated new drug application |
| NDA : New drug application |
| 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 |
| URS: User Requirement Specification |
| FAT: Factory Acceptance Testing |
| SAT : Site Acceptance Test |
| IQ : Installation Qualification |
| DQ : Design Qualification |
| OQ : Operational Qualification |
| PQ: Performance Qualification |
| FBD: Fluid-bed dryer |
| FBP: Fluid-bed Processor |
| RMG : Rapid mixer Granulator |
| FDC: Fixed Dose Combination |
| FEFO: First expiry first out |
| FG: Finished Goods |
| FIFO: First in first out |
| FMEA: Failure modes and effect 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 |
| DOP: Dioctyl Phthalate |
| 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 |
| DHS : Dry heat sterilization |
| 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 Pharmacopeia |
| IPA: Isopropyl Alcohol |
| IPS: In process control |
| IQ: Installation qualification |
| IR: Immediate release |
| ISO: International Organization for Standardization |
| ISPE: International Society for Pharmaceutical Engineering |
| IV: Intravenous |
| KOS: Knowledge organization system |
| LAF: Laminar air flow |
| LAL: Limulus Amoebocyte Lysate |
| LD: Lethal dose |
| LD50: Lethal dose where 50% of the animal population die |
| LDPE: Low Density Polyethylene |
| LIMS: Laboratory Information Management System |
| LIR: Laboratory Investigation Report |
| 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 |
| MCC: Medicines control council (South Africa) |
| MDD: Maximum daily dose |
| MFR: Master Formula Record |
| WL: Warning letter |
| MOA: Method Of Analysis |
| 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 |
| OQ: Operation Qualification |
| OSD: Oral Solid Dosage |
| OSHA: Occupational Safety And Health Administration |
| OTC: Over-the-counter |
| OOS: Out of specification |
| OOT: Out of trend |
| PAC: Post-approval changes |
| PAO: Poly alpha olefin |
| PAT: Process Analytical technology |
| PET: Preservative efficacy test |
| PLC: Programmable Logical Control |
| PVC: Polyvinyl Chloride |
| PVDC: Polyvinylidene Chloride |
| PW: Purified Water |
| QBD : Quality by design |
| QM: Quality Manual |
| QMS: Quality Management System |
| RH: Relative humidity |
| RLAF: Reverse laminar air flow |
| RLD: Reference listed drug |
| RM: Raw material |
| RM: Packing material |
| FGS: Finished Goods Store |
| BSR: Bounded store Room |
| RO: Reverse Osmosis |
| RS: Related Substance |
| SAT: Site Acceptance 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 |
| TOC: Total organic carbon |
| TSE: Transmissible spongiform encephalopathy |
| USP: United States Pharmacopeia |
| USP-NF: United States Pharmacopeia-National Formulary |
| CMS: Continuous monitoring system |
| VMP: Validation Master Plan |
| WFI: Water for injection |
| TRF : Test Request Form |
| CFR: Code of Federal Regulations |
| CFU: Colony Forming Unit |
| cGMP: Current Good Manufacturing Practices |
| CIP: Clean in place |
| COA: Certificate of analysis |
| MOA: Method of analysis |
| COS: Certificate of suitability |
| COPP: Certificate of Pharmaceutical Products |
| CPP: Critical Process Parameter |
| DMF: Drug master file |
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