190-PHARMA ABBREVIATION

190-PHARMA ABBREVIATION 

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