PHARMA ABBREVIATION
- AADA: Abbreviated antibiotic drug application
- ADE: Adverse drug event
- ADME: Absorption, distribution, metabolism, and excretion
- AHU: Air Handling Unit
- ANDA: Abbreviated new drug application
- ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)
- AP: Applicants Part (of EDMF)
- API: Active pharmaceutical ingredient
- APR: Annual product review (APQR – Annual product quality review)
- AQL: Acceptable quality level
- AR: Analytical Reagent
- ASHRAE: American Society of heating, Refrigeration and Air Conditioning Engineers
- ASM: Active Substance Manufacturer
- ASMF: Active Substance Master File
- AST: Accelerated stability testing
- ASTM: American Society for Testing and Materials
- BA/BE: Bioavailability/bioequivalence
- BCS: Biopharmaceutical classification system
- BET: Bacterial Endotoxin Test
- BFS: Blow Fill Seal
- BI: Biological Indicator
- BMR: Batch Manufacturing/Processing Record
- BOD: Biological Oxygen Demand
- BOM: Bill of Materials
- BOPP: Biaxially Oriented Polypropylene
- BP: British Pharmacopoeia
- BPR: Batch Packaging Record
- BRMS: Biologics Regulatory Management System
- BSE: Bovine spongiform encephalopathy (mad cow disease)
- 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 drug standard control organization (India)
- CEP: Certification of suitability of European Pharmacopoeia monographs
- CFR: Code of Federal Regulations
- CFU: Colony Forming Unit
- cGMP: Current Good Manufacturing Practices
- CIP: Clean in place
- CMC: Chemistry, manufacturing and controls
- CMS: Continuous monitoring system
- COA: Certificate of analysis
- COS: Certificate of suitability
- COPP: Certificate of Pharmaceutical Products
- CPP: Critical Process Parameter
- CQA: Critical Quality Attribute
- CTD: Common technical document
- 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 (formerly European Medicines Evaluation Agency)
- EP: European Pharmacopoeia
- EPS: Expanded polystyrene
- ETP: Effluent Treatment Plant
- EU: Endotoxin unit
- EU: European Union
- FAT: Factory Acceptance Testing
- FBD: Fluid-bed dryer
- FDA: Food and Drug Administration,United States
- 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
- GGP: good guidance 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
- ICAH: 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
- JP: Japanese Pharmacopoeia
- 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
- MEDSAFE: Medicines and medicinal devices safety authority (New zealand)
- MHRA: Medicines and Healthcare products Regulatory Agency (UK)
- 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
- PET: Polyethylene
- PIC/S: Pharmaceutical Inspection Co-operation Scheme
- PLC: Programmable Logic Control
- PQ: Performance Qualification
- PVC: Polyvinyl Chloride
- PVDC: Polyvinylidene Chloride
- PW: Purified Water
- QA : Quality Assurance
- QC: Quality Control
- QbD: Quality by design
- QM: Quality Manual
- QSD: Quality System Dossier
- QSM : Quality System Management
- QMS: Quality Management System
- RH: Relative humidity
- RLAF: Reverse laminar air flow
- RLD: Reference listed drug
- RM: Raw material
- RO: Reverse Osmosis
- ROPP: Roll On Pilfer Proof
- RS: Related Substance
- SAL: Sterility Assurance Level
- SAT: Site Acceptance Testing
- SDN: Screening Deficiency Notice (Canada)
- SIP: Sterilization in place/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
- TC: Thermocouple
- TDS: Total Dissolved Solids
- TGA: Therapeutics goods administration (Australia)
- TOC: Total organic carbon
- TSE: Transmissible spongiform encephalopathy
- USFDA: United states foods and drugs administration
- USP: United States Pharmacopeia
- USP-NF: United States Pharmacopeia-National Formulary
- URS: User Requirement Specification
- VAI: Voluntary action indicated
- VMP: Validation Master Plan
- WFI: Water for injection
- WHO: World Health Organisation
- WL: Warning letter