Pharmaceutical Industry Acronyms and Abbreviations

The most common Abbreviations Used in Pharmaceutical Industry and different countries’ Regulatory authorities are mentioned below. This extensive collection of abbreviations and acronyms is very helpful for freshers.

Some of these abbreviations you can find during the documentation of Production, Quality Assurance, and Quality Control sectors for the formulation of any dosage forms.

This pharmaceutical industry abbreviations pdf includes Regulatory affairs abbreviations, abbreviations used in Pharmacovigilance (PV), cGMP, Clinical trials, Quality Assurance, Quality Control, and Dosage abbreviations chart, etc.

This database is updated regularly to catch up with new terminologies, abbreviations, and acronyms of the Indian pharmaceutical industry.

Abbreviations Used In Pharmaceutical Industry

Pharma Abbreviations with ‘A’

AADA	Abbreviated Antibiotic Drug Application
AAO	American Academy of Ophthalmology
ADE	Adverse Drug Effects
ADME	Absorption Distribution Metabolism Excretion
ADI	Acceptable Daily Intake
ADS	Adverse Drug Reactions
Acronym Refers to Acceptable, Legible, Contemporaneous, Original, and Accurate	Adverse Drug Reporting System
AGDUFA	Animal Generic Drug User Fee Act
AHU	Air Handling Unit
ALCOA	Acronym Referring to Acceptable, Legible, Contemporaneous, Original, and Accurate
ALCOA+	Absorption, Metabolism, and Excretion
AME	Analysis of Variance
ANDA	Abbreviated New Drug Application
ANOVA	Agencia Nacional De Vigilancia Sanitaria [National Health Surveillance Agency, Brazil]
ANVISA	Active Pharmaceutical Ingredients Committee
AP	Applicants Part
API	Active Pharmaceutical Ingredients
APIC	Active Pharmaceutical Ingredients Comitee
AQL	Acceptable Quality Level
APR	Annual Products Report
AR	Analytical Reagents
ARB	Angiotensin Receptor Blockers
ASM	Active Substance Manufacturer
ASMF	Active Substance Master File
ASTM	American Society For Testing and Materials
AST	Accelerated Stability Testing

Pharma Abbreviations with ‘B’

BA	Bio Availability
BE	Bio Equivalence
BET	Bacterial Endotoxin Test
BFS	Blow Fill Seal
BI	Biological Indication
BIND	Biological Investigational New Drug
BLA	Biologics Licence Application
BMI	Body Mass Index
BMR	Batch Manufacturing Record
BOM	Bill of Materials
BOPP	Bio-oxially Oriented Poly Propylene
BP	British Pharmacopoeia
BPR	Batch Packaging Record
BPC	Bulk Pharmaceutical Chemical
BRMS	Biologics Regulatory Management System
BSA	Body Surface Area
BSE	Bovine Spongiform Encephalopathy
BsUFA	Biosimilar User Fee Act
BSI	British Standard Institute
BTD	Breakthrough Therapy Destination
BVC	British Veterinary Codex
BOD	Biological Oxygen Demand

Pharma Abbreviations with ‘C’

CA	Chemical Abstracts
CAPA	Corrective and Preventive Action
CANDA	Computer-Assisted Product Licence Application
CAPLA	Committee on Veterinary Medical Products
CAS	Chemical Abstracts Service
CDSCO	Central Drug Standard Control Organization
CFR	Code of Federal Regulation
CFU	Colony Forming Unit
CGMP	Current Good Manufacturing Practices
CMO	Contract Manufacturing Organization
CMS	Continuous Monitoring System
COA	Certificate of Analysis
COP	Clean Out of Place
COPP	Certificate of Pharmaceutical Product
COS	Certificate of Suitability
CPI	Consumer Price Index
CPP	Critical Process Parameter
CRO	Contract Research Organization
CRS	Contamination Response System
CQA	Critical Quality Attribute
CT	Clinical Trials
CTD	Common Technical Documents
CVMP	Commitee on Veterinary Medical Products
COD	Chemical Oxygen Demand

Pharma Abbreviations with ‘D’

DIW	De Ionised Water
DIN	Drug Identification Number
DP	Drug Products
DI	Data Integrity
DOA	Drugs of Abuse
DOE	Design of Experiments
DOP	Dioctyl Phthalate
DPI	Dry Powder Injection
DQ	Design Qualification
DS	Drug Substance

Pharma Abbreviations with ‘E’

EC	European Commitee
ED	Effective Dose
EDMF	European Drug Master File
EDQM	European Directorate for the Quality of Medicine
EFPIA	European Federation of Pharmaceutical Industries and Association
EFTA	European Free Trade Association
EIA	Enzyme Immuno Assay
EIR	Establishment Inspection Report
EMA	European Medicine Agency
EP	European Pharmacopoeia
EPAR	European Public Assessment Report
EPS	Expanded Poly Styrene
ERP	Enterprise Resource Planning
ETP	Effluent Treatment Plant
EU	Endotoxin Unit

Pharma Abbreviations with ‘F’

FAI	Further Action Indicated
FAR	Field Alert Report
FAT	Fixed-Dose Combination
FDA	Food and Drug Administration
FDC	Fixed-dose combination
FEFO	First Expiry First Out
FEI	Facility Establishment Identifier
FBD	Fluid Bed Dryer
FG	Finished Goods
FGTN	Finished Goods Transfer Note
FIFO	First In First Out
FOI	Freedom of Information
FR	Federal Register
FTA	Fault Tree Analysis

Pharma Abbreviations with ‘G’

GC	Gas Chromatography
GCLP	Good Clinical Laboratory Practices
GLP	Good Laboratory Practices
GIT	Gastro Intestinal Tract
GMO	Genetically Modified Organisms
GMP	Good Manufacturing Practices
GDP	Good Documentation Practices
GHP	Good Housekeeping Practices
GPT	Growth Promotion Test
GRP	Good Review Practices

Pharma Abbreviations with ‘H’

HACCP	Hazard Analysis Critical Control Point
HCI	High-Efficiency Particulate Air
HDPE	High Density Polyethylene
HEPA	High-Performance Liquid Chromatography
HMI	Human Machine Interface
HPLC	High Performance Liquid Chromatography
HSA	Health Sciences Authority
HVAC	Heating Ventilation Air Condition

Pharma Abbreviations with ‘I’

ICH	International Council For Harmonization
IND	Investigational New Drugs
INDA	Investigational New Drug Application
INN	International Nonproprietary Names
In-Process Product Container	Intra Muscular
IP	Indian Pharmacopoeia
IPA	Iso Propyl Alcohol
IV	Intra Venous
IPCS	International Programme On Chemical Safety
IPEC	International Pharmaceutical Excipients Councils
IPC	Indian Pharmacopoeia Commission
IPC	In Process Control
IQ	Installation Qualification
IR	Immediate Release
ISO	International Organisations For Organization
ISPE	International Society For Pharmaceutical Engineering
IUPAC	International Union of Pure and Applied Chemistry

Pharma Abbreviations with ‘J’

JP	Japanese Pharmacopoeia
JAJ	Johnson & Johnson Inc

Pharma Abbreviations with ‘K’

KOS	Knowledge Organization System
KFT	Karl Fisher Titration

Pharma Abbreviations with ‘L’

LAL	Limulus Amoebocyte Lysate
LAN	Local Area Network
LAF	Laminar Air Flow
LD	Lethal Dose
LDPE	Letter of Agreement
LIMS	Laboratory Management System
LIR	Laboratory Investigation Report
LOD	Loss On Drying
LOD	Limit of Detection
LOA	Letter if Agreement
LOA	Letter of Authorization
LOQ	Limit of Quantification
LR	Laboratory Reagents
LVPs	Large Volume Parenterals

Pharma Abbreviations with ‘M’

MAC	Maximum Allowable Carryover
MAH	Marketing Authorization Holder
MDI	Metered Dose Inhaler
MDD	Maximum Daily Dose
MDR	Medical Device Reporting
MEDSAFE	Medicines and Medicinal Devices Safety Authority
MHRA	Medicines and Healthcare Products Regulatory Agency
MLD	Minimum Lethal Dose
MOA	Method of Analysis
MFR	Master Formula Record
MRP	Maximum Retail Price
MS	Mass Spectroscopy
MSDS	Materials Safety Data Sheet
MTD	Maximum Tolerated Dose

Pharma Abbreviations with ‘N’

NCE	New Chemical Entity
NAI	Non-Conformance Report
NCR	Non Conforming reports
NDA	New Drug Application
NDC	National Drug Code
NF	National Formulary
NIR	Near Infrared Spectroscopy
NME	New Molecular Entity
NMR	Nuclear Magnetic Resonance Spectroscopy
NMT	Not More Than
NOC	Notice of Compliance
NOD	Notice of Deficiency
NON	Notice of Non-compliance
NSAID	Non-Steroidal Anti Inflammatory Drug

Pharma Abbreviations with ‘O’

OAI	Official Action Indicated
ODI	Orally Disintegrating Tablets
OEL	Occupational Exposure Level
OQ	Operational Qualification
OSD	Oral Solid Dosage
OSHA	Occupational Safety and Health Administration
OOS	Out of Specifications
OOT	Out Of Trend
OTC	Over The Counter

Pharma Abbreviations with ‘P’

PAC	Post Approval Changes
PACT	Post Approval Commitment Tracking
PAI	Pre Approval Inspection
PAO	Poly Alpha Olefin
PAS	Prior Approval Supplement
PAT	Process Analytical Technology
PD	Pharmacodynamics
PDA	Parenteral Drug Association
PK	Pharmacokinetics
Post Marketing Surveillance	Product Licence Application
PLC	Programmable Logic Control
PMS	Post-Marketing Surveillance
PMD	Product Management Department
POM	Prescription Only Medicines
PPB	Parts Per Billion
PPE	Personal Protective Equipment
PPM	Parts Per Million
PPT	Personal Protective Transfer
PV	Process Validation
PVC	Poly Vinyl Chloride
PVDC	Poly Vinyl Di Chloride
PW	Purified Water

Pharma Abbreviations with ‘Q’

QA	Quality Assurance
QC	Quality Control
QbD	Quality By Design
QM	Quality Manual
QMS	Quality Management System
QP	Qualified Person
QRM	Quality Risk Management
QSD	Quality System Dossier
QSM	Quality System Management
QU	Quality Unit

Pharma Abbreviations with ‘R’

RCR	Risk Control Review
R & D	Research and Development
RLAF	Reverse Laminar Air Flow
RLD	Reference Listen Drug
RH	Relative Humidity
RM	Raw Materials
RS	Related Substance
RMS	Raw Materials Store
RMG	Rapid Mixer Granulator
RTR	Refuse To Receive

Pharma Abbreviations with ‘S’

SAL	Sterility Assurance Level
SAT	Site Acceptance Test
SIP	Steam In Place
Scale-up and Post-Approval Changes	Subject Matter Expert
SMF	Site Master File
SPM	Secondary Packaging Materials
SLS	Sodium Lauryl Sulphate
SOP	Standard Operating Procedure
STD	Sexually Transmitted Disease
SUPAC	Scale-up and Post Approval Changes
SVP	Small Volume Parenteral
SWFI	Sterile Water For Injection

Pharma Abbreviations with ‘T’

TC	Thermo Couple
TDI	Tolerable Daily Intake
TDS	Total Dissolved Solids
TGA	Therapeutic Goods Administration
TLC	Thin Layer Chromatography
TOC	Total Organic Carbon
TSE	Transmissible Spongiform Encephalopathy

Pharma Abbreviations with ‘U’

USP	United State Pharmacopoeia
USPC	United States Pharmacopoeial Convention
USP-NF	United State Pharmacopoeia – National Formulatory
URS	User Requirements Specifications
USC	United State Code
UTD	Urinary Tract Infection

Pharma Abbreviations with ‘V’

VAF	Virus Antibody Free
VTD	Voluntary Action Indicated
VAI	Volumatory Action Indicated
VMP	Validation Master Plan

Pharma Abbreviations with ‘W’

WBC	White Blood Cells
WC	Working Conformation
WDA	Wholesale Dealer’s Licence
WI	Working Instructions
WFI	Water For Injection
WOE	Waiting of Evidence
WHO	World Health Organization
WL	Warning Latter

Country Regulatory Authority Name

If an Indian pharmaceutical company gets approval from a foreign regulatory authority, then that company can export its products to that particular country.

All the Regulatory Affairs terminology is provided below with the country and the name of the regulatory authority. So it is important to remember the names of all these regulatory authorities.

Country Name	Name of Regulatory Authority
Australia	Therapeutics Goods Administration (TGA)
Brazil	Agencia Nacional De Vigilancia Sanitoria (ANVISA)
Canada	Health Canada
China	State Food and Drug Administration
Costa Rica	Ministry of Health
Colombia	Ministry of Health
Denmark	Danish Medicines Agency (DMA)
Europe	European Medicines Agency (EMA)
Germany	Federal Institute For Medical Drugs and Devices
Hong Kong	Department of Health; Pharmaceutical Services
India	Central Drug Standard Control Organization (CDSCO)
Ireland	Irish Medicines Board (IMB)
Italy	Italian Pharmaceutical Agency (IPA)
Japan	Ministry of Health, Labour and Welfare
Kenya	Pharmacy Poison Board (PPB)
Malaysia	National Pharmaceutical Control Bureau, Ministry of Health
New Zealand	Medsafe, Medicines and Medical Devices Safety Authority
Netherlands	Medicines Evaluation Board (MEB)
Nigeria	National Agency For Food and Drug Administration and Control
Pakistan	Drugs Control Organization, Ministry of Health
Paraguay	Ministry of Health
Romania	Ministry of Health
Saudi Arabia	Ministry of Health
Sweden	Medical Products Agency (MPA)
South Africa	Medicines Control Council (MCC)
Sri Lanka	SPC, Ministry of Health
Switzerland	Swissmedic, Swiss Agency For Therapeutic Products
Singapore	Center for Pharmaceutical Administration Health Sciences Authority
Thailand	Ministry of Health
USA	Food and Drug Administration
UK	Medicines and Healthcare Products Regulatory Agency
Ukrain	Ministry of Health
Uganda	Uganda National Council For Science and Technology

FAQs Related to Abbreviations Used in the Pharmaceutical Industry

Q1. What is the abbreviation for pharmaceuticals?

Ans. If anyone has Pharmaceuticals acronyms and pharmaceutical abbreviations regarding good knowledge the doing of work should be easy in the Pharmaceutical Industry.

Q2. What does PRC mean in pharma?

Ans. Common Industry acronyms and abbreviations PRC is most commonly used. This Pharma-related full form indicated the quality standards, which stands for Patient Review and Coordination.

Q3. What does pm stand for in the pharmaceutical industry?

Ans. Precision medicine (PM) is the most important acronym in the pharmaceutical healthcare community.

Q4. What is the full form of USFDA?

Ans. USFDA’s full form is the United States Food and Drug Administration. USFDA enforced current Good Manufacturing Practices (cGMP).

Q5. What stands for PMD in the Pharmaceutical Industry?

Ans. PMD in the Pharmaceutical Industry stands for Product Management Department.

Q6. What is TGA’s full form in pharma?

Ans. TGA stands for Therapeutic Goods Administration. This is the name of the Regulatory Authority of Australia.

Q7. What is MHRA’s full form in Pharma?

Ans. MHRA stands for Medicines and Healthcare Products Agency, which is the regulatory authority of the UK country.

Q8. In Pharmaceutical Industry COA stands for…..?

Ans. In the Pharmaceutical Industry common acronyms includes COA. This stands for Certificate of Analysis.

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