Pharma Abbreviations


  1. AADA: Abbreviated antibiotic drug application
  2. ADE: Adverse drug event
  3. ADME: Absorption, distribution, metabolism, and excretion
  4. AHU: Air Handling Unit
  5. ANDA: Abbreviated new drug application
  6. ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)
  7. AP: Applicants Part (of EDMF)
  8. API: Active pharmaceutical ingredient
  9. APR: Annual product review (APQR – Annual product quality review)
  10. AQL: Acceptable quality level
  11. AR: Analytical Reagent
  12. ASHRAE: American Society of heating, Refrigeration and Air Conditioning Engineers
  13. ASM: Active Substance Manufacturer
  14. ASMF: Active Substance Master File
  15. AST: Accelerated stability testing
  16. ASTM: American Society for Testing and Materials
  17. BA/BE: Bioavailability/bioequivalence
  18. BCS: Biopharmaceutical classification system
  19. BET: Bacterial Endotoxin Test
  20. BFS: Blow Fill Seal
  21. BI: Biological Indicator
  22. BMR: Batch Manufacturing/Processing Record
  23. BOD: Biological Oxygen Demand
  24. BOM: Bill of Materials
  25. BOPP: Biaxially Oriented Polypropylene
  26. BP: British Pharmacopoeia
  27. BPR: Batch Packaging Record
  28. BRMS: Biologics Regulatory Management System
  29. BSE: Bovine spongiform encephalopathy (mad cow disease)
  30. CAPA: Corrective and preventive action
  31. CBE: Changes being effected
  32. CBER: Center for Biologics Evaluation and Research (FDA)
  33. CCIT: Container closure integrity test
  34. CDER: Center for Drug Evaluation and Research (FDA)
  35. CDSCO: Central drug standard control organization (India)
  36. CEP: Certification of suitability of European Pharmacopoeia monographs
  37. CFR: Code of Federal Regulations
  38. CFU: Colony Forming Unit
  39. cGMP: Current Good Manufacturing Practices
  40. CIP: Clean in place
  41. CMC: Chemistry, manufacturing and controls
  42. CMS: Continuous monitoring system
  43. COA: Certificate of analysis
  44. COS: Certificate of suitability
  45. COPP: Certificate of Pharmaceutical Products
  46. CPP: Critical Process Parameter
  47. CQA: Critical Quality Attribute
  48. CTD: Common technical document
  49. DMF: Drug master file
  50. DOP: Dioctyl Phthalate
  51. DQ: Design Qualification
  52. EDMF: European drug master file
  53. EDQM: European Directorate for the Quality of Medicines
  54. EH&S: Environmental health and safety
  55. EIR: establishment inspection report (FDA)
  56. EMEA: European Medicines Agency (formerly European Medicines Evaluation Agency)
  57. EP: European Pharmacopoeia
  58. EPS: Expanded polystyrene
  59. ETP: Effluent Treatment Plant
  60. EU: Endotoxin unit
  61. EU: European Union
  62. FAT: Factory Acceptance Testing
  63. FBD: Fluid-bed dryer
  64. FDA: Food and Drug Administration,United States
  65. FDC: Fixed Dose Combination
  66. FEFO: First expiry first out
  67. FG: Finished Goods
  68. FIFO: First in first out
  69. FMEA: Failure modes and effect analysis
  70. FOI: Freedom of information
  71. GAMP: Good automated manufacturing practice
  72. GC: Gas Chromatography
  73. GCLP: Good clinical laboratory practice
  74. GCP: Good clinical practice
  75. GDP: Good distribution practice
  76. GEP: Good engineering practice
  77. GGP: good guidance practice
  78. GIT: Gastrointestinal Tract
  79. GLP: Good laboratory practice
  80. GMO: Genetically modified organism
  81. GMP: Good manufacturing practice
  82. GPT: Growth Promotion Test
  83. GRAS/E: Generally recognized as safe and effective
  84. GRP: Good review practice
  85. HACCP: Hazard analysis critical control point
  86. HDPE: High Density Polyethylene
  87. HEPA: High efficiency particulate air (filter)
  88. HPLC: High performance liquid chromatography 
  89. HSA: Health Sciences Authority, Singapore
  90. HVAC: Heating, ventilating, and air conditioning
  91. ICAH: International Conference on Harmonisation
  92. IH: In house
  93. IM: Intramuscular
  94. IND: Investigational new drug
  95. INDA: Investigational new drug application
  96. IP: Indian Pharmacopeia
  97. IPA: Isopropyl Alcohol
  98. IPS: In process control
  99. IQ: Installation qualification
  100. IR: Immediate release
  101. ISO: International Organization for Standardization
  102. ISPE: International Society for Pharmaceutical Engineering
  103. IV: Intravenous
  104. JP: Japanese Pharmacopoeia
  105. KOS: Knowledge organization system
  106. LAF: Laminar air flow
  107. LAL: Limulus Amoebocyte Lysate
  108. LD: Lethal dose
  109. LD50: Lethal dose where 50% of the animal population die
  110. LDPE: Low Density Polyethylene
  111. LIMS: Laboratory Information Management System
  112. LIR: Laboratory Investigation Report
  113. LOD: Loss on drying
  114. LOD: Limit of detection
  115. LOQ: Limit of quantification
  116. LR: Laboratory Reagent
  117. LVPs: Large Volume Parenterals
  118. MA: Marketing Authorisation
  119. MAA: Marketing Authorisation Application
  120. MAC: Maximum Allowable Carryover
  121. MCC: Medicines control council (South Africa)
  122. MDD: Maximum daily dose
  123. MFR: Master Formula Record
  124. MEDSAFE: Medicines and medicinal devices safety authority (New zealand) 
  125. MHRA: Medicines and Healthcare products Regulatory Agency (UK)
  126. MOA: Method Of Analysis
  127. MSDS: Material Safety Data Sheets
  128. NCE: New chemical entity
  129. NDA: New Drug Application
  130. NF: National Formulary
  131. NIR: Near Infra Red Spectroscopy
  132. NON: Notice of non-compliance (Canada)
  133. ODI: Orally Disintegrating Tablet
  134. OQ: Operation Qualification
  135. OSD: Oral Solid Dosage
  136. OSHA: Occupational Safety And Health Administration
  137. OTC: Over-the-counter
  138. OOS: Out of specification
  139. OOT: Out of trend
  140. PAC: Post-approval changes
  141. PAO: Poly alpha olefin
  142. PAT: Process Analytical technology
  143. PET: Preservative efficacy test
  144. PET: Polyethylene
  145. PIC/S: Pharmaceutical Inspection Co-operation Scheme
  146. PLC: Programmable Logic Control
  147. PQ: Performance Qualification
  148. PVC: Polyvinyl Chloride
  149. PVDC: Polyvinylidene Chloride
  150. PW: Purified Water
  151. QA : Quality Assurance
  152. QC: Quality Control
  153. QbD: Quality by design
  154. QM: Quality Manual
  155. QSD: Quality System Dossier
  156. QSM : Quality System Management
  157. QMS: Quality Management System
  158. RH: Relative humidity
  159. RLAF: Reverse laminar air flow
  160. RLD: Reference listed drug
  161. RM: Raw material
  162. RO: Reverse Osmosis
  163. ROPP: Roll On Pilfer Proof
  164. RS: Related Substance
  165. SAL: Sterility Assurance Level
  166. SAT: Site Acceptance Testing
  167. SDN: Screening Deficiency Notice (Canada)
  168. SIP: Sterilization in place/Steam in place
  169. SLS: Sodium Lauryl Sulphate
  170. SMF: Site master file
  171. SOP: Standard operating procedure
  172. SPE: Society for Pharmaceutical Engineering
  173. SUPAC: Scale-up and post approval changes
  174. SVP: Small Volume Parenteral
  175. TC: Thermocouple
  176. TDS: Total Dissolved Solids
  177. TGA: Therapeutics goods administration (Australia)
  178. TOC: Total organic carbon
  179. TSE: Transmissible spongiform encephalopathy
  180. USFDA: United states foods and drugs administration
  181. USP: United States Pharmacopeia
  182. USP-NF: United States Pharmacopeia-National Formulary
  183. URS: User Requirement Specification
  184. VAI: Voluntary action indicated
  185. VMP: Validation Master Plan
  186. WFI: Water for injection
  187. WHO: World Health Organisation
  188. WL: Warning letter

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