FullForms / Pharma Full Forms List

S.No Acronym Full Form
1 AADA Abbreviated Antibiotic Drug Application
2 AAO American Academy of Ophthalmology
3 ADE Adverse Drug Event
4 ADME Absorption, Distribution, Metabolism, and Excretion
5 ADI Acceptable Daily Intake
6 ADR Adverse Drug Reaction
7 ADRS Adverse Drug Reporting System
8 AGDUFA Animal Generic Drug User Fee Act
9 AHU Air Handling Unit
10 ALCOA Acronym referring to Attributable, Legible, Contemporaneous, Original and Accurate.
11 ALCOA PLUS Acronym referring to Attributable, Legible, Contemporaneous, Original and Accurate ‘plus’ Complete, Consistent, Enduring, and Available.
12 AME Absorption, Metabolism, Excretion
13 ANDA Abbreviated New Drug Application
14 ANOVA Analysis of Variance
15 ANVISA Agência Nacional de Vigilância Sanitária
16 AP Applicants Part (of EDMF)
17 API Active Pharmaceutical Ingredient
18 APIC Active Pharmaceutical Ingredients Committee
19 APR Annual product review (APQR – Annual product quality review)
20 AQL Acceptable Quality Level
21 AR Analytical Reagent
22 ARB Angiotensin Receptor Blocker
23 ASHRAE American Society of heating, Refrgeration and
24 ACE Air Conditioning Engineers
25 ASM Active Substance Manufacturer
26 ASME American Society of Mechanical Engineers
27 ASMF Active Substance Master File
28 ASQ American Society for Quality
29 AST Accelerated Stability Testing
30 ASTM American Society for Testing and Materials
31 BA/BE Bioavailability / Bioequivalence
32 BCS Biopharmaceutical Classification System
33 BET Bacterial Endotoxin Test
34 BFS Blow Fill Seal
35 BI Biological Indicator
36 BIND Biological Investigational New Drug
37 BLA Biologics License Application (CBER)
38 BMI Body Mass Index
39 BMR Batch Manufacturing / Processing Record
40 BOD Biological Oxygen Demand
41 BOM Bill of Materials
42 BOPP Biaxially Oriented Polypropylene
43 BP British Pharmacopoeia
44 BPC Bulk Pharmaceutical Chemical
45 BPR Batch Packaging Record
46 BRMS Biologics Regulatory Management System
47 BSA Body Surface Area
48 BSE Bovine Spongiform Encephalopathy (Mad Cow Disease)
49 BSI British Standards Institute
50 BST Bovine Somatotropin
51 BsUFA Biosimilar User Fee Act
52 BTD Breakthrough Therapy Designation
53 BVC British Veterinary Codex
54 CA Chemical Abstracts
55 CAPA Corrective and preventive action
56 CANDA Computer Assisted New Drug Application
57 CAPLA Computer Assisted Product License Application
58 CAS Chemical Abstracts Service
59 CBE Changes Being Effected
60 CBER Center for Biologics Evaluation and Research (FDA)
61 CCIT Container Closure Integrity Test
62 CDER Center for Drug Evaluation and Research (FDA)
63 CDRH Center for Devices and Radiological Health (FDA)
64 CDSCO Central Drug Standard Control Organization (India)
65 CEP Certification of Suitability of European Pharmacopoeia Monographs
66 CFR Code of Federal Regulations
67 CFU Colony Forming Unit
68 CJD Creutzfeldt Jakob Disease
69 cGMP Current Good Manufacturing Practices
70 CIP Clean in Place
71 CMC Chemistry, Manufacturing and Controls
72 CMO Contract Manufacturing Organization
73 CMS Continuous Monitoring System
74 CNS Central Nervous System
75 COA Certificate of Analysis
76 COI Conflict of Interest
77 COMSTAT Compliance Status Information System
78 COP Clean out of Place
79 COPP Certificate of Pharmaceutical Products
80 CoS Certificate of Suitability
81 CPI Consumer Price Index
82 CPP Critical Process Parameter
83 CQA Critical Quality Attribute
84 CR Complete Response (Letter)
85 CRO Contract Research Organization
86 CRS Contamination Response System
87 CSA Controlled Substances Act
88 CSV Computer System Validation
89 CT Clinical Trial
90 CTD Common Technical Document
91 CVMP Committee on Veterinary Medical Products (EMA)
92 DI Deionized Water
93 DIN Drug Identification Number (Canada)
94 DMF Drug Master File
95 DOA Drugs of Abuse
96 DOE Design of Experiment
97 DOP Dioctyl Phthalate
98 DQ Design Qualification
99 DP Drug Product
100 DPC PTR Act Drug Price Competition and Patent Trade Restoration Act of 1984
101 DPI Dry Powder Inhaler
102 DS Drug Substance
103 DUNS Data Universal Numbering System
104 EC European Community
105 ED Effective Dose
106 EDMF European Drug Master File
107 EDQM European Directorate for the Quality of Medicines
108 EFOIA Electronic Freedom of Information Act
109 EFPIA European Federation of Pharmaceutical Industries and Associations
110 EFTA European Free Trade Association
111 EH&S Environmental Health and Safety
112 EIA Enzyme Immunoassay
113 EIR Establishment Inspection Report (FDA)
114 EMA European Medicines Agency
115 EP European Pharmacopoeia
116 EPAR European Public Assessment Reports (EMEA)
117 EPS Expanded Polystyrene
118 ERP Emergency Response Plan
119 ERS Electronic Regulatory Submission
120 ERSR Electronic Regulatory Submissions and Review
121 ESG Electronic Submissions Gateway
122 ETP Effluent Treatment Plant
123 EU Endotoxin Unit
124 EU European Union (EU 27)
125 FAI Further Action Indicated (FDA)
126 FAR Field Alert Report (FDA)
127 FAT Factory Acceptance Testing
128 FBD Fluid Bed Dryer
129 FDA Food and Drug Administration, United States
130 FDA Form 482 FDA form for Notice of Inspection
131 FDA 483 FDA form Used as a Written Notice of Deficiencies Found in Inspections
132 FDA SRS Spontaneous Reporting System of the Food and Drug Administration
133 FDC Food, Drug, & Cosmetic
134 FDC Fixed Dose Combination
135 FDCA Federal Food, Drug, and Cosmetic Act of 1938
136 FFDCA Federal Food, Drug, and Cosmetic Act of 1938
137 FEI Facility Establishment Identifier
138 FEFO First Expiry First Out
139 FG Finished Goods
140 FIFO First in First Out
141 FMEA Failure Modes and Effect Analysis
142 FMECA Failure Modes Effects and Criticality Analysis
143 FOI Freedom of Information
144 FOIA Freedom of Information Act
145 FR Federal Register
146 FTA Fault Tree Analysis
147 GAMP Good Automated Manufacturing Practice
148 GARR Grants Application Review Request
149 GC Gas Chromatography
150 GCLP Good Clinical Laboratory Practice
151 GCP Good Clinical practice
152 GDP Good Distribution practice
153 GEO Genetically Engineered Organism
154 GEP Good Engineering Practice
155 GGP Good Guidance practice
156 GIT Gastrointestinal Tract
157 GLP Good Laboratory Practice
158 GMO Genetically Modified Organism
159 GMP Good Manufacturing Practice
160 GPT Growth Promotion Test
161 GRAS Generally Recognized as Safe
162 GRAS/E Generally Recognized as Safe and Effective
163 GRP Good Review Practice
164 GUDUFA Generic Drug User Fee Amendments
165 GxP "Good x"" Practices
166 HACCP Hazard Analysis Critical Control Point
167 HCI Human Computer Interaction
168 HDPE High Density Polyethylene
169 HEPA High Efficiency Particulate Air (filter)
170 HMI Human Machine Interface
171 HPLC High Performance Liquid Chromatography
172 HSA Health Sciences Authority, Singapore
173 HVAC Heating, Ventilating, and Air Conditioning
174 ICAH International Council on Harmonisation
175 IH In House
176 IM Intramuscular
177 IND Investigational New Drug
178 INDA Investigational New Drug Application
179 INN International Nonproprietary Name
180 IP Indian Pharmacopeia
181 IPA Isopropyl Alcohol
182 IPC In process Control
183 IPCS International Programme on Chemical Safety (WHO)
184 IPEC International Pharmaceutical Excipients Council
185 IQ Installation Qualification
186 IR Immediate Release
187 IR Information Request (Letter)
188 ISO International Organization for Standardization
189 ISPE International Society for Pharmaceutical Engineering
190 IUPAC International Union of Pure and Applied Chemistry
191 IV Intravenous
192 JP Japanese Pharmacopoeia
193 KOS Knowledge Organization System
194 LAF Laminar air flow
195 LAL Limulus Amoebocyte Lysate
196 LAN Local Area Network
197 LD Lethal Dose
198 LD50 Lethal Dose where 50% of the Animal Population Die
199 LDPE Low Density Polyethylene
200 LIMS Laboratory Information Management System
201 LIR Laboratory Investigation Report
202 LOA Letter of Agreement
203 LOA Letter of Authorization
204 LOD Loss on Drying
205 LOD Limit of Detection
206 LOQ Limit of Quantification
207 LR Laboratory Reagent
208 LVPs Large Volume Parenterals
209 MA Marketing Authorisation
210 MAA Marketing Authorisation Application
211 mAb Monoclonal Antibody
212 MAC Maximum Allowable Carryover
213 MAH Marketing Authorisation Holder (EC)
214 MDA Medical Devices Agency (UK)
215 MDD Maximum Daily Dose
216 MDI Metered Dose Inhaler
217 MDR Medical Device Reporting
218 MDUFMA Medical Device User Fee and Modernization Act of 2002
219 MDUFSA Medical Device User Fee Stabilization Act of 2005
220 MFR Master Formula Record
221 MEDSAFE Medicines and Medicinal Devices Safety Authority (New Zealand)
222 MHRA Medicines and Healthcare Products Regulatory Agency (UK)
223 MLD Minimum Lethal Dose
224 MOA Method Of Analysis
225 MRA Mutual Recognition Agreement
226 MS Mass Spectroscopy
227 MSDS Material Safety Data Sheets
228 MTD Maximum Tolerated Dose
229 NCE New Chemical Entity
230 NAI No Action Indicated(FDA)
231 NCR Non Conformance Report
232 NDA New Drug Application
233 NDC National Drug Code (FDA)
234 NF National Formulary
235 NIR Near Infra Red Spectroscopy
236 NME New Molecular Entity
237 NMR Nuclear Magnetic Resonance Spectroscopy
238 NMT Not More Than
239 NOAEL No Observable Adverse Effect Level
240 NOC Notice of Compliance (Canada)
241 NOD Notice of Deficiency (Canada
242 NON Notice of Non compliance (Canada)
243 NSAID Non Steroidal Anti Inflammatory Drug
244 OAI Official Action Indicated(FDA)
245 ODI Orally Disintegrating Tablet
246 OEL Occupational Exposure Level
247 OQ Operation Qualification
248 OSD Oral Solid Dosage
249 OSHA Occupational Safety And Health Administration
250 OOS Out of Specification
251 OOT Out of Trend
252 OTC Over the counter
253 PAC Post approval changes
254 PACT Post Approval Commitment Tracking
255 PAI Pre Approval Inspection(FDA)
256 PAO Poly alpha olefin
257 PAS Prior Approval Supplement(FDA)
258 PAT Process Analytical technology
259 PD Pharmacodynamics
260 PDA Parenteral Drug Association
261 PDE Permitted Daily Exposure
262 PDUFA Prescription Drug User Fee Act
263 PEPFAR Presidential Emergency Plan for AIDS Relief
264 PET Preservative Efficacy Test
265 PET Polyethylene
266 Ph.Eur. Pharmacopeia Europa
267 PIC/S Pharmaceutical Inspection Co operation Scheme
268 PK Pharmacokinetics
269 PLA Product License Application (CBER)
270 PLAIR Pre Launch Activities Importation Request (USFDA)
271 PLC Programmable Logic Control
272 PMA Premarket Approval
273 PMF Public Master File
274 PMS Postmarketing Surveillance
275 POM Prescription only medicine (UK)
276 ppb Parts per Billion
277 PPE Personal protective equipment
278 Ppm Parts per Million
279 PPM Planned Preventive Maintenance
280 PQ Performance Qualification
281 PQG Pharmaceutical Quality Group
282 PUDUFA Prescription Drug User Fee Act (FDA)
283 PV Process Validation
284 PVC Polyvinyl Chloride
285 PVDC Polyvinylidene Chloride
286 PW Purified Water
287 QA Quality Assurance
288 QC Quality Control
289 QbD Quality by design
290 QbR Question based Review
291 QD Once Daily
292 QID Four Times a Day
293 QM Quality Manual
294 QMS Quality Management System
295 QOD Every Other Day
296 QP Qualified Person (EU)
297 QRM Quality Risk Management
298 QSD Quality System Dossier
299 QSM Quality System Management
300 QU Quality Unit
301 RCR Risk Control Review
302 R&D Research and Development
303 REMS Risk Evaluation and Mitigation Strategy
304 RH Relative Humidity
305 RLAF Reverse Laminar Air Flow
306 RLD Reference listed drug
307 RM Raw Material
308 RMS Reference Member State (Europe)
309 RO Reverse Osmosis
310 ROPP Roll On Pilfer Proof
311 RS Related Substance
312 RTR Refuse to Receive
313 Rx Prescription
314 SAL Sterility Assurance Level
315 SAT Site Acceptance Test
316 SDN Screening Deficiency Notice (Canada)
317 SHPRA South African Health Products Authority [formally known as Medicines Control Council (MCC)
318 SIP Sterilization in lace/Steam in place
319 SLS Sodium Lauryl Sulphate
320 SME Subject Matter Expert
321 SMF Site Master File
322 SOP Standard Operating Procedure
323 SPE Society for Pharmaceutical Engineering
324 STD Sexually Transmitted Disease
325 SUPAC Scale up and Post Approval Changes
326 SVP Small Volume Parenteral
327 TC Thermocouple
328 TDI Tolerable Daily Intake
329 TDS Total Dissolved Solids
330 TGA Therapeutics Goods Administration (Australia)
331 TLC Thin Layer Chromatography
332 TID Three Times a Day
333 TOC Total Organic Carbon
334 TSE Transmissible Spongiform Encephalopathy
335 UDI Unique Device Identification
336 UNII Unique Ingredient Identifier
337 USFDA United States Foods and Drugs Administration
338 USP United States Pharmacopeia
339 USPC U.S. Pharmacopeial Convention
340 USP NF United States Pharmacopeia National Formulary
341 URS User Requirement Specification
342 UTI Urinary tract infection
343 VAI Voluntary Action Indicated
344 VMP Validation Master Plan
345 WFI Water for Injection
346 WHO World Health Organisation
347 WL Warning letter


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