Abbreviations Used in Pharmaceutical Industry with Regulatory Authority 2022

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

This article contains a glossary of pharmaceutical terms and acronyms used in the healthcare and pharmaceutical industry. We use these common pharmaceutical abbreviations during day-to-day practice and in the profession.

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 Pharma related full form can make it difficult to understand for people who haven’t spent most of their time in the pharmaceutical industry’s various sectors.

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

Abbreviations Used In Pharmaceutical Industry

Like all other specialized industries, pharmaceutical industry is full of abbreviations. We have gathered the ones our experts use the most in the table below.

We try to give a short list of common abbreviations you may have seen on any documentation, any equipment, lab or other test results.

Abbreviations Used in Pharmaceutical Industry with Regulatory Authority
Abbreviations Used in Pharmaceutical Industry
AADAAbbreviated Antibiotic Drug Application
AAOAmerican Academy of Ophthalmology
ADEAdverse Drug Effects
ADMEAbsorption Distribution Metabolism Excretion
ADIAcceptable Daily Intake
ADRAdverse Drug Reactions
ADRSAdverse Drug Reporting System
AGDUFAAnimal Generic Drug User Fee Act
AHUAir Handling Unit
ALCOAAcronym Referring to Acceptable, Ligible, Contemporaneous, Original and Accurate
ALCOA+Acronym Referring to Acceptable, Ligible, Contemporaneous, Original and Accurate, Complete Consistent, Enduring and Available
AMEAbsorption, Metabolism and Excretion
ANDAAbbreviated New Drug Application
ANOVAAnalysis of Vacience
ANVISAAgencia Nacional De Vigilancia Sanitoria [National Health Surveillance Agency, Brazil]
APApplicants Part
APIActive Pharmaceutical Ingredients
APICActive Pharmaceutical Ingredients Comitee
AQLAcceptable Quality Level
APRAnnual Products Report
ARAnalytical Reagents
ARBAngiotensin Receptor Blockers
ASMActive Substance Manufacturer
ASMFActive Substance Master File
ASTMAmerican Society For Testing and Materials
ASTAccelerated Stability Testing
BABio Availability
BEBio Equivalence
BETBacterial Endotoxin Test
BFSBlow Fill Seal
BIBiological Indication
BINDBiological Investigational New Drug
BLABiologics Licence Application
BMIBody Mass Index
BMRBatch Manufacturing Record
BOMBill of Materials
BOPPBio-oxially Oriented Poly Propylene
BPBritish Pharmacopoeia
BPRBatch Packaging Record
BPCBulk Pharmaceutical Chemical
BRMSBiologics Regulatory Management System
BSABody Surface Area
BSE Bovine Spongiform Encephalopathy
BsUFABiosimilar User Fee Act
BSIBritish Standard Institute
BTDBreakthrough Therapy Destination
BVCBritish Veterinary Codex
BODBiological Oxygen Demand
CAChemical Abstracts
CAPACorrective and Preventive Action
CANDAComputer Assisted New Drug Application
CAPLAComputer Assisted Product Licence Application
CASChemical Abstracts Service
CDSCOCentral Drug Standard Control Organization
CFRCode of Federal Regulation
CFUColony Forming Unit
CGMPCurrent Good Manufacturing Practices
CMOContract Manufacturing Organization
CMSContinuous Monitoring System
COACertificate of Analysis
COPClean Out of Place
COPPCertificate of Pharmaceutical Product
COSCertificate of Suitability
CPIConsumer Price Index
CPPCritical Process Parameter
CROContract Research Organization
CRSContamination Response System
CQACritical Quality Attribute
CTClinical Trials
CTDCommon Technical Documents
CVMPCommitee on Veterinary Medical Products
CODChemical Oxygen Demand
DIWDe Ionised Water
DINDrug Identification Number
DPDrug Products
DIData Integrity
DOADrugs of Abuse
DOEDesign of Experiments
DOPDioctyl Phthalate
DPIDry Powder Injection
DQDesign Qualification
DSDrug Substance
ECEuropean Commitee
EDEffective Dose
EDMFEuropean Drug Master File
EDQMEuropean Directorate for the Quality of Medicine
EFPIAEuropean Federation of Pharmaceutical Industries and Association
EFTAEuropean Free Trade Association
EIAEnzyme Immuno Assay
EIREstablishment Inspection Report
EMAEuropean Medicine Agency
EPEuropean Pharmacopoeia
EPAREuropean Public Assessment Report
EPSExpanded Poly Styrene
ERPEnterprise Resource Planning
ETPEffluent Treatment Plant
EUEndotoxin Unit
FAIFurther Action Indicated
FARField Alert Report
FATFactoey Acceptance Report
FDAFood and Drug Administration
FDCFixed Dose Combination
FEFOFirst Expiry First Out
FEIFacility Establishment Identifier
FBDFluid Bed Dryer
FGFinished Goods
FGTNFinished Goods Transfer Note
FIFOFirst In First Out
FOIFreedom of Information
FRFederal Register
FTAFault Tree Analysis
GCGas Chromatography
GCLPGood Clinical Laboratory Practices
GLPGood Laboratory Practices
GITGastro Intestinal Tract
GMOGenetically Modified Organisms
GMPGood Manufacturing Practices
GDPGood Documentation Practices
GHPGood Housekeeping Practices
GPTGrowth Promotion Test
GRPGood Review Practices
HACCPHazard Analysis Critical Control Point
HCIHuman Computer Interface
HDPEHigh Density Polyethylene
HEPAHigh Efficiency Particulate Air
HMIHuman Machine Interface
HPLCHigh Performance Liquid Chromatography
HSAHealth Sciences Authority
HVACHeating Ventilation Air Condition
ICHInternational Council For Harmonization
INDInvestigational New Drugs
INDAInvestigational New Drug Application
INNInternational Nani proprietary Name
IMIntra Muscular
IPIndian Pharmacopoeia
IPAIso Propyl Alcohol
IVIntra Venous
IPCSInternational Programme On Chemical Safety
IPECInternational Pharmaceutical Excipients Councils
IPCIn Process Product Container
IPCIn Process Control
IQInstallation Qualification
IRImmediate Release
ISOInternational Organisations For Organization
ISPEInternational Society For Pharmaceutical Engineering
IUPACInternational Union of Pure and Applied Chemistry
JPJapanese Pharmacopoeia
JAJJohnson & Johnson Inc
KOSKnowledge Organization System
KFTKarl Fisher Titration
LALLimulus Amoebocyte Lysate
LANLocal Area Network
LAFLaminar Air Flow
LDLethal Dose
LDPELow Density Polyethylene
LIMSLaboratory Management System
LIRLaboratory Investigation Report
LODLoss On Drying
LODLimit of Detection
LOALetter if Agreement
LOALetter of Authorization
LOQLimit of Quantification
LRLaboratory Reagents
LVPsLarge Volume Parenterals
MACMaximum Allowable Carryover
MAHMarketing Authorization Holder
MDIMetered Dose Inhaler
MDDMaximum Daily Dose
MDRMedical Device Reporting
MEDSAFEMedicines and Medicinal Devices Safety Authority
MHRAMedicines and Healthcare Products Regulatory Agency
MLDMinimum Lethal Dose
MOAMethod of Analysis
MFRMaster Formula Record
MRPMaximum Retail Price
MSMass Spectroscopy
MSDSMaterials Safety Data Sheet
MTDMaximum Tolerated Dose
NCENew Chemical Entity
NAINon Action Indicated
NCRNon Conformance Report
NDANew Drug Application
NDCNational Drug Code
NFNational Formulary
NIRNear Infrared Spectroscopy
NMENew Molecular Entity
NMRNuclear Magnetic Resonance Spectroscopy
NMTNot More Than
NOCNotice of Compliance
NODNotice of Deficiency
NONNotice of Non-compliance
NSAIDNon-Steroidal Anti Inflammatory Drug
OAIOfficial Action Indicated
ODIOrally Disintegrating Tablets
OELOccupational Exposure Level
OQOperational Qualification
OSDOral Solid Dosage
OSHAOccupational Safety and Health Administration
OOSOut of Specifications
OOTOut Of Trend
OTCOver The Counter
PACPost Approval Changes
PACTPost Approval Commitment Tracking
PAIPre Approval Inspection
PAOPoly Alpha Olefin
PASPrior Approval Supplement
PATProcess Analytical Technology
PDPharmacodynamics
PDAParenteral Drug Association
PKPharmacokinetics
PLAProduct Licence Application
PLCProgrammable Logic Control
PMSPost Marketting Surveillance
PMDProduct Management Department
POMPrescription Only Medicines
PPBParts Per Billion
PPEPersonal Protective Equipment
PPMParts Per Million
PPTPersonal Protective Transfer
PVProcess Validation
PVCPoly Vinyl Chloride
PVDCPoly Vinyl Di Chloride
PWPurified Water
QAQuality Assurance
QCQuality Control
QbDQuality By Design
QMQuality Manual
QMSQuality Management System
QPQualified Person
QRMQuality Risk Management
QSDQuality System Dossier
QSMQuality System Management
QUQuality Unit
RCRRisk Control Review
R & DResearch and Development
RLAFReverse Laminar Air Flow
RLDReference Listen Drug
RHRelative Humidity
RMRaw Materials
RSRelated Substance
RMSRaw Materials Store
RMGRapid Mixer Granulator
RTRRefuse To Receive
SALSterility Assurance Level
SATSite Acceptance Test
SIPSteam In Place
SMESubject Matter Expert
SMFSite Master File
SPMSecondary Packaging Materials
SLSSodium Lauryl Sulphate
SOPStandard Operating Procedure
STDSexually Transmitted Disease
SUPACScale-up and Post Approval Changes
SVPSmall Volume Parenteral
SWFISterile Water For Injection
TCThermo Couple
TDITolerable Daily Intake
TDSTotal Dissolved Solids
TGATherapeutic Goods Administration
TLCThin Layer Chromatography
TOCTotal Organic Carbon
TSETransmissible Spongiform Encephalopathy
USPUnited State Pharmacopoeia
USPCUnited States Pharmacopoeial Convention
USP-NFUnited State Pharmacopoeia – National Formulatory
URSUser Requirements Specifications
USCUnited State Code
UTDUrinary Tract Infection
VAFVirus Antibody Free
VTDVaccum Tray Dryer
VAIVolumatory Action Indicated
VMPValidation Master Plan
WBCWhite Blood Cells
WCWorking Conformation
WDAWholesale Dealer’s Licence
WIWorking Instructions
WFIWater For Injection
WOEWaiting of Evidence
WHOWorld Health Organization
WLWarning 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 besides 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
AustraliaTherapeutics Goods Administration (TGA)
BrazilAgencia Nacional De Vigilancia Sanitoria (ANVISA)
CanadaHealth Canada
ChinaState Food and Drug Administration
Costa RicaMinistry of Health
ColombiaMinistry of Health
DenmarkDanish Medicines Agency (DMA)
EuropeEuropean Medicines Agency (EMA)
GermanyFederal Institute For Medical Drugs and Devices
Hong KongDepartment of Health; Pharmaceutical Services
IndiaCentral Drug Standard Control Organization (CDSCO)
IrelandIrish Medicines Board (IMB)
ItalyItalian Pharmaceutical Agency (IPA)
JapanMinistry of Health, Labour and Welfare
KenyaPharmacy Poison Board (PPB)
MalaysiaNational Pharmaceutical Control Bureau, Ministry of Health
New ZealandMedsafe, Medicines and Medical Devices Safety Authority
NetherlandsMedicines Evaluation Board (MEB)
NigeriaNational Agency For Food and Drug Administration and Control
PakistanDrugs Control Organization, Ministry of Health
ParaguayMinistry of Health
RomaniaMinistry of Health
Saudi ArabiaMinistry of Health
SwedenMedical Products Agency (MPA)
South AfricaMedicines Control Council (MCC)
Sri LankaSPC, Ministry of Health
SwitzerlandSwissmedic, Swiss Agency For Therapeutic Products
SingaporeCenter for Pharmaceutical Administration Health Sciences Authority
ThailandMinistry of Health
USAFood and Drug Administration
UKMedicines and Healthcare Products Regulatory Agency
UkrainMinistry of Health
UgandaUganda National Council For Science and Technology

Some FAQs Related to Abbreviations Used in Pharmaceutical Industry

What is the abbreviation for pharmaceuticals?

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

What does PRC mean in pharma?

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.

What does pm stand for in the pharmaceutical industry?

Several abbreviations are used in the healthcare and pharmaceutical sector. Precision medicine (PM) is the most important acronym in the pharmaceutical healthcare community.

What is the full form of USFDA?

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

What stands for PMD in Pharmaceutical Industry?

PMD in Pharmaceutical Industry stands for Product Management Department.

What is TGA full form in pharma?

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

What is MHRA full form in Pharma?

If you know the overview of the pharmaceutical industry then you may hear this abbreviation. MHRA stands for Medicines and Healthcare Products Agency, which is the regulatory authority of the UK country.

In Pharmaceutical Industry COA stands for…..?

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

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Conclusion

In this article we share about Abbreviations Used In Pharmaceutical Industry with regulatory authority of some countries. Hope this information will cater the needs of both fresher’s and experienced professionals.

The ultimate goal of The Pharmacy Study website is to become a knowledge hub by gathering all Pharmaceutical journal abbreviation related information under one roof.

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