Friday, 20 December 2013

Common Abbreviations Used In Pharmaceutical Industry



Common Abbreviations & Acronyms Used In Pharmaceuticals



 Pharmatreasures abbreviations data base is the best available abbreviation collection which extensively lists out common and useful acronyms and abbreviations related to the pharmaceutical industry.

 This collection includes, abbreviations  connected with Regulatory affairs, Pharmacovigilance (PV), Clinical trials, cGMP, Quality Assurance, Quality Control etc. This data base is updated on regular basis (last updated on 10th March 2020) to catch up new terminologies.


AADA: 
Abbreviated Antibiotic Drug Application
AAO:
American Academy of Ophthalmology  
ADE: 
Adverse Drug Event
ADME: 
Absorption, Distribution, Metabolism, and Excretion
ADI:
Acceptable Daily Intake
ADR:
Adverse Drug Reaction
ADRS: 
Adverse Drug Reporting System
AGDUFA:
Animal Generic Drug User Fee Act       
AHU: 
Air Handling Unit
ALCOA:
Acronym referring to Attributable, Legible, Contemporaneous, Original and Accurate.
ALCOA PLUS:
Acronym referring to Attributable, Legible, Contemporaneous, Original and Accurate ‘plus’ Complete, Consistent, Enduring, and Available.
AME:
Absorption, Metabolism, Excretion
ANDA: 
Abbreviated New Drug Application
ANOVA:
Analysis of Variance
ANVISA: 
Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)
AP: 
Applicants Part (of EDMF)
API: 
Active Pharmaceutical Ingredient
APIC:
Active Pharmaceutical Ingredients Committee
APR: 
Annual product review (APQR – Annual product quality review)
AQL: 
Acceptable Quality Level
AR: 
Analytical Reagent
ARB:
Angiotensin Receptor Blocker
ASHRAE: 

American Society of heating, Refrgeration and
 Air Conditioning Engineers
ASM: 
Active Substance Manufacturer
ASME:
American Society of Mechanical Engineers
ASMF: 
Active Substance Master File
ASQ:
American Society for Quality
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
BIND:
Biological Investigational New Drug
BLA:
Biologics License Application (CBER)
BMI:
Body Mass Index
BMR: 
Batch Manufacturing/Processing Record
BOD: 
Biological Oxygen Demand
BOM: 
Bill of Materials
BOPP: 
Biaxially Oriented Polypropylene
BP: 
British Pharmacopoeia
BPC:
Bulk Pharmaceutical Chemical
BPR:  
Batch Packaging Record
BRMS: 
Biologics Regulatory Management System
BSA:
Body Surface Area
BSE: 
Bovine Spongiform Encephalopathy (Mad Cow Disease)
BSI:
British Standards Institute
BST:
Bovine Somatotropin
BsUFA:
Biosimilar User Fee Act      
BTD:
Breakthrough Therapy Designation
BVC:
British Veterinary Codex
CA:   
Chemical Abstracts
CAPA: 
Corrective and preventive action
CANDA:
Computer Assisted New Drug Application
CAPLA:
Computer Assisted Product License Application
CAS:
Chemical Abstracts Service
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)
CDRH: 
Center for Devices and Radiological Health (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
CJD:
Creutzfeldt Jakob Disease
cGMP: 
Current Good Manufacturing Practices
CIP: 
Clean in Place
CMC: 
Chemistry, Manufacturing and Controls
CMO:
Contract Manufacturing Organization
CMS: 
Continuous Monitoring System
CNS:
Central Nervous System
COA: 
Certificate of Analysis
COI:
Conflict of Interest
COMSTAT:
Compliance Status Information System
COP:
Clean out of Place
COPP: 
Certificate of Pharmaceutical Products
CoS:
Certificate of Suitability
CPI:
Consumer Price Index
CPP: 
Critical Process Parameter
CQA: 
Critical Quality Attribute
CR:
Complete Response (Letter)
CRO:
Contract Research Organization
CRS: 
Contamination Response System
CSA:
Controlled Substances Act
CSV:
Computer System Validation
CT:
Clinical Trial
CTD: 
Common Technical Document
CVMP:
Committee on Veterinary Medical Products (EMA)
DI:
Deionized Water
DIN:
Drug Identification Number (Canada)
DMF:
Drug Master File
DOA:
Drugs of Abuse
DOE:
Design of Experiment
DOP: 
Dioctyl Phthalate
DQ: 
Design Qualification
DP:
Drug Product
DPC-PTR Act:                       
Drug Price Competition and Patent Trade Restoration Act of 1984
DPI:
Dry Powder Inhaler
DS:
Drug Substance
DUNS:
Data Universal Numbering System
EC:
European Community 
ED:
Effective Dose
EDMF: 
European Drug Master File
EDQM: 
European Directorate for the Quality of Medicines
EFOIA:
Electronic Freedom of Information Act
EFPIA:
European Federation of Pharmaceutical Industries and Associations
EFTA:
European Free Trade Association
EH&S: 
Environmental Health and Safety
EIA:
Enzyme Immunoassay
EIR: 
Establishment Inspection Report (FDA)
EMA: 
European Medicines Agency (Formerly European Medicines Evaluation Agency -EMEA)
EP:
European Pharmacopoeia
EPAR:
European Public Assessment Reports (EMEA)
EPS: 
Expanded Polystyrene
ERP:
Emergency Response Plan
ERS:
Electronic Regulatory Submission
ERSR: 
Electronic Regulatory Submissions and Review
ESG:
Electronic Submissions Gateway
ETP: 
Effluent Treatment Plant
EU: 
Endotoxin Unit
EU: 
European Union (EU 27)
FAI:
Further Action Indicated (FDA)
FAR:
Field Alert Report (FDA)
FAT: 
Factory Acceptance Testing
FBD: 
Fluid-Bed Dryer
FDA: 
Food and Drug Administration, United States
FDA Form 482:
FDA form for Notice of Inspection
FDA-483:
FDA form Used as a Written Notice of Deficiencies Found in Inspections
FDA-SRS:                           
Spontaneous Reporting System of the Food and Drug Administration
FDC:
Food, Drug, & Cosmetic
FDC: 
Fixed Dose Combination
FDCA:
Federal Food, Drug, and Cosmetic Act of 1938
FFDCA:
Federal Food, Drug, and Cosmetic Act of 1938
FEI:
Facility Establishment Identifier
FEFO: 
First Expiry First Out
FG: 
Finished Goods
FIFO: 
First in First Out
FMEA: 
Failure Modes and Effect Analysis
FMECA:
Failure Modes Effects and Criticality Analysis
FOI: 
Freedom of Information
FOIA:
Freedom of Information Act
FR:
Federal Register
FTA:
Fault Tree Analysis
GAMP: 
Good Automated Manufacturing Practice
GARR:
Grants Application Review Request
GC:
Gas Chromatography
GCLP:
Good Clinical Laboratory Practice
GCLP: 
Good Clinical laboratory practice
GCP: 
Good Clinical practice
GDP: 
Good Distribution practice
GEO:
Genetically Engineered Organism
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: 
Generally Recognized as Safe
GRAS/E: 
Generally Recognized as Safe and Effective
GRP: 
Good Review Practice
GUDUFA:
Generic Drug User Fee Amendments
GxP:
"Good x"" Practices
HACCP: 
Hazard Analysis Critical Control Point
HCI:
Human-Computer Interaction
HDPE: 
High Density Polyethylene
HEPA: 
High Efficiency Particulate Air (filter)
HMI: 
Human Machine Interface
HPLC: 
High Performance Liquid Chromatography 
HSA: 
Health Sciences Authority, Singapore
HVAC: 
Heating, Ventilating, and Air Conditioning
ICAH: 
International Council on Harmonisation (Formally known as International Conference on Harmonisation)
IH: 
In House
IM: 
Intramuscular
IND: 
Investigational New Drug
INDA: 
Investigational New Drug Application
INN:
International Nonproprietary Name
IP: 
Indian Pharmacopeia
IPA: 
Isopropyl Alcohol
IPC:
In process Control
IPCS:
International Programme on Chemical Safety (WHO)
IPEC:
International Pharmaceutical Excipients Council
IQ: 
Installation Qualification
IR: 
Immediate Release
IR:
Information Request (Letter)
ISO: 
International Organization for Standardization
ISPE: 
International Society for Pharmaceutical Engineering
IUPAC:
International Union of Pure and Applied Chemistry
IV: 
Intravenous
JP: 
Japanese Pharmacopoeia
KOS: 
Knowledge Organization System
LAF: 
Laminar air flow
LAL:  
Limulus Amoebocyte  Lysate
LAN:
Local Area Network
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
LOA:
Letter of Agreement
LOA:
Letter of Authorization
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
mAb:
Monoclonal Antibody         
MAC: 
Maximum Allowable Carryover
MAH:
Marketing Authorisation Holder (EC)
MDA:
Medical Devices Agency (UK)
MDD: 
Maximum Daily Dose
MDI:
Metered Dose Inhaler
MDR:
Medical Device Reporting
MDUFMA:
Medical Device User Fee and Modernization Act of 2002
MDUFSA:
Medical Device User Fee Stabilization Act of 2005
MFR: 
Master Formula Record
MEDSAFE: 
Medicines and Medicinal Devices Safety Authority (New Zealand)  
MHRA: 
Medicines and Healthcare Products Regulatory Agency (UK)
MLD:
Minimum Lethal Dose
MOA: 
Method Of Analysis
MRA:
Mutual Recognition Agreement
MS:
Mass Spectroscopy
MSDS: 
Material Safety Data Sheets
MTD:
Maximum Tolerated Dose
NCE: 
New Chemical Entity
NAI:
No Action Indicated(FDA)
NCR:
Non-Conformance Report
NDA: 
New Drug Application
NDC:
National Drug Code (FDA)
NF: 
National Formulary
NIR: 
Near Infra Red Spectroscopy
NME:
New Molecular Entity
NMR:
Nuclear Magnetic Resonance Spectroscopy
NMT: 
Not More Than
NOAEL:
No Observable Adverse Effect Level
NOC:
Notice of Compliance (Canada)
NOD:
Notice of Deficiency (Canada
NON: 
Notice of Non-compliance (Canada)
NSAID:
Non-Steroidal Anti-Inflammatory Drug         
OAI:
Official Action Indicated(FDA)
ODI: 
Orally Disintegrating Tablet
OEL:
Occupational Exposure Level
OQ: 
Operation Qualification
OSD: 
Oral Solid Dosage
OSHA: 
Occupational Safety And Health Administration
OOS: 
Out of Specification
OOT: 
Out of Trend
OTC:
Over-the-counter
PAC: 
Post-approval changes
PACT:
Post-Approval Commitment Tracking
PAI: 
Pre-Approval Inspection(FDA)
PAO: 
Poly alpha olefin
PAS:
Prior Approval Supplement(FDA)
PAT: 
Process Analytical technology
PD:
Pharmacodynamics
PDA:
Parenteral Drug Association 
PDE:
Permitted Daily Exposure
PDUFA:
Prescription Drug User Fee Act
PEPFAR:
Presidential Emergency Plan for AIDS Relief
PET: 
Preservative Efficacy Test
PET: 
Polyethylene
Ph.Eur.:
Pharmacopeia Europa
PIC/S:  
Pharmaceutical Inspection Co-operation Scheme
PK:
Pharmacokinetics
PLA: 
Product License Application (CBER)
PLAIR:
Pre-Launch Activities Importation Request (USFDA)
PLC:  
Programmable Logic Control
PMA:
Premarket Approval
PMF:
Public Master File
PMS: 
Postmarketing Surveillance
POM:
Prescription-only medicine (UK)
ppb:
Parts per Billion
PPE:
Personal protective equipment
Ppm:
Parts per Million
PPM:
Planned Preventive Maintenance
PQ: 
Performance Qualification
PQG:
Pharmaceutical Quality Group
PUDUFA:
Prescription Drug User Fee Act (FDA)
PV:
Process Validation
PVC: 
Polyvinyl Chloride
PVDC: 
Polyvinylidene Chloride
PW: 
Purified Water
QA :  
Quality Assurance
QC:  
Quality Control
QbD: 
Quality by design
QbR:
Question-based Review
QD:
Once Daily   
QID:
Four Times a Day
QM: 
Quality Manual
QMS:
Quality Management System
QOD:
Every Other Day
QP:
Qualified Person (EU)
QRM:
Quality Risk Management
QSD:  
Quality System Dossier
QSM: 
Quality System Management
QU:
Quality Unit
RCR:
Risk Control Review
R&D:
Research and Development
REMS:
Risk Evaluation and Mitigation Strategy
RH: 
Relative Humidity
RLAF: 
Reverse Laminar Air Flow
RLD: 
Reference listed drug
RM: 
Raw Material
RMS:
Reference Member State (Europe)
RO: 
Reverse Osmosis
ROPP: 
Roll On Pilfer Proof
RS: 
Related Substance
RTR:
Refuse to Receive
Rx:
Prescription
SAL: 
Sterility Assurance Level
SAT: 
Site Acceptance Test
SDN: 
Screening Deficiency Notice (Canada)
SHPRA
South African Health Products Authority [formally known as Medicines Control Council (MCC)]
SIP: 
Sterilization in lace/Steam in place
SLS: 
Sodium Lauryl Sulphate
SME:
Subject Matter Expert
SMF: 
Site Master File
SOP: 
Standard Operating Procedure
SPE:  
Society for Pharmaceutical Engineering
STD:
Sexually Transmitted Disease
SUPAC: 
Scale-up and Post Approval Changes
SVP:  
Small Volume Parenteral
TC: 
Thermocouple
TDI:
Tolerable Daily Intake
TDS: 
Total Dissolved Solids
TGA: 
Therapeutics Goods Administration (Australia)
TLC:
Thin Layer Chromatography
TID:
Three Times a Day
TOC: 
Total Organic Carbon
TSE: 
Transmissible Spongiform Encephalopathy
UDI:
Unique Device Identification
UNII:
Unique Ingredient Identifier
USFDA: 
United States Foods and Drugs Administration
USP: 
United States Pharmacopeia
USPC:
U.S. Pharmacopeial Convention
USP-NF: 
United States Pharmacopeia-National Formulary
URS: 
User Requirement Specification
UTI:
Urinary tract infection
VAI: 
Voluntary Action Indicated
VMP: 
Validation Master Plan
WFI: 
Water for Injection
WHO: 
World Health Organisation
WL: 
Warning letter



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