Pharmaceutical abbreviations

Pharmaceutical abbreviations

When working in the pharmaceutical industry and doing the associated business with the pharmaceutical industry, you will encounter various terms and pharmaceutical and bio-pharmaceutical abbreviations. Here we tried to cover most of them as a ready reference.

Merriam-Webster’s Medical Dictionary

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AADAAbbreviated Antibiotic Drug Application
AAOAmerican Academy Of Ophthalmology
ABLAAbbreviated Biologics License Application
ADCsAntibody-Drug Conjugates
ADEAdverse Drug Event
ADIAcceptable Daily Intake
ADMEAbsorption, Distribution, Metabolism, And Excretion
ADRAdverse Drug Reaction
ADRSAdverse Drug Reporting System
AEAdverse Event
AGDUFAAnimal Generic Drug User Fee Act
AHUAir Handling Unit
ALCOAAcronym Referring To Attributable, Legible, Contemporaneous, Original And Accurate.
ALCOA PLUSAcronym Referring To Attributable, Legible, Contemporaneous, Original And Accurate ‘Plus’ Complete, Consistent, Enduring, And Available.
AMEAbsorption, Metabolism, Excretion
AMPAverage Manufacturer Price
ANDAAbbreviated New Drug Application
ANOVAAnalysis Of Variance
ANVISAAgência Nacional De Vigilância Sanitária (National Health Surveillance Agency Brazil)
APApplicants Part (Of EDMF)
APIActive Pharmaceutical Ingredient. Also Referred To As “Active Ingredient.”
APICActive Pharmaceutical Ingredients Committee
APRAnnual Product Review (APQR – Annual Product Quality Review)
AQLAcceptable Quality Level
ARAnalytical Reagent
ARBAngiotensin Receptor Blocker
ASHRAEAmerican Society Of Heating, Refrigeration And Air Conditioning Engineers
ASMActive Substance Manufacturer
ASMEAmerican Society Of Mechanical Engineers
ASMFActive Substance Master File
ASPAverage Sales Price.
ASQAmerican Society For Quality
ASTAccelerated Stability Testing
ASTMAmerican Society For Testing And Materials
AWPAverage Wholesale Price
BA/BEBioavailability/Bioequivalence
BCSBiopharmaceutical Classification System
BETBacterial Endotoxin Test
BFSBlow Fill Seal
BIBiological Indicator
BINDBiological Investigational New Drug
BLABiologics License Application
BMIBody Mass Index
BMRBatch Manufacturing/Processing Record
BODBiological Oxygen Demand
BOMBill Of Materials
BOPPBiaxially Oriented Polypropylene
BPBritish Pharmacopoeia
BPCBulk Pharmaceutical Chemical
BPCIABiologics Price Competition And Innovation Act (2009)
BPRBatch Packaging Record
BRMSBiologics Regulatory Management System
BSABody Surface Area
BSEBovine Spongiform Encephalopathy
BSEBovine Spongiform Encephalopathy (Mad Cow Disease)
BSIBritish Standards Institute
BSTBovine Somatotropin
BsUFABiosimilar User Fee Act
BTDBreakthrough Therapy Designation
BVCBritish Veterinary Codex
CAChemical Abstracts
CANDAComputer Assisted New Drug Application
CAPACorrective Action And Preventive Action
CAPLAComputer Assisted Product License Application
CASChemical Abstracts Service
CBEChanges Being Effected
CBERCenter For Biologics Evaluation And Research
CCITContainer Closure Integrity Test
CDERCenter For Drug Evaluation And Research
CDRHCenter For Devices And Radiological Health
CDSCOCentral Drug Standard Control Organization (India)
CEPCertification Of Suitability Of European Pharmacopoeia Monographs
CFRCode Of Federal Regulations
CFUColony Forming Unit
cGMPCurrent Good Manufacturing Practices
CHOChinese Hamster Ovaries
CIPClean In Place
CIPClean In Place
CJDCreutzfeldt Jakob Disease
CMCChemistry, Manufacturing And Controls
CMOContract Manufacturing Organization
CMSCenters For Medicare And Medicaid Services
CNSCentral Nervous System
COACertificate Of Analysis
COCCertificate Of Conformance/ Compliance
COIConflict Of Interest
COPClean Out Of Place
COPPCertificate Of Pharmaceutical Products
CoSCertificate Of Suitability
CPIConsumer Price Index
CPPCritical Process Parameter
CPVContinued Process Verification
CQACritical Quality Attribute
CRChild Resistant
CRFCase Report Form
CRLComplete Response Letter
CROContract Research Organization
CRSContamination Response System
CSAControlled Substances Act
CSVComputer System Validation
CTClinical Trial
CTDCommon Technical Document
CVMPCommittee On Veterinary Medical Products (Ema)
DAWDispense As Written
DDSDrug Delivery Systems
DGCIDrug Controller General Of India
DIDeionized Water
DINDrug Identification Number (Canada)
DMFDrug Master File
DNADeoxyribonucleic Acid
DOADrugs Of Abuse
DOEDesign Of Experiment
DOPDioctyl Phthalate
DPDrug Product
DPC-PTR ActDrug Price Competition And Patent Trade Restoration Act Of 1984
DPIDry Powder Inhaler
DQDesign Qualification
DSDrug Substance
DSMBClinical Trials Data And Safety Monitoring Board
DTCDirect To Consumer Advertising
DUNSData Universal Numbering System
EACEstimated Acquisition Cost
ECEuropean Community
ECTDElectronic Common Technical Document,
EDEffective Dose
EDMFEuropean Drug Master File
EDQMEuropean Directorate For The Quality Of Medicines
EFOIAElectronic Freedom Of Information Act
EFPIAEuropean Federation Of Pharmaceutical Industries And Associations
EFTAEuropean Free Trade Association
EH&SEnvironmental Health And Safety
EHSEnvironmental Health And Safety
EIAEnzyme Immunoassay
EIREstablishment Inspection Report
EMAEuropean Medicines Agency (Formerly European Medicines Evaluation Agency -EMEA)
EPEuropean Pharmacopoeia
EPAREuropean Public Assessment Reports (EMEA)
EPOErythropoietin
EPSExpanded Polystyrene
ERPEmergency Response Plan
ERSElectronic Regulatory Submission
ERSRElectronic Regulatory Submissions And Review
ESCAElectron Spectroscopy For Chemical Analysis
ESGElectronic Submissions Gateway
ETPEffluent Treatment Plant
EUEndotoxin Unit
EUEuropean Union
FABAn Antibody Fragment That Contains The Regions That Bind To Antigens
FAIFurther Action Indicated
FARField Alert Report
FATFactory Acceptance Testing
FBDFluid-Bed Dryer
FDA Form 482FDA Form For Notice Of Inspection
FDAUs Food And Drug Administration
FDA-483FDA Form Used As A Written Notice Of Deficiencies Found In Inspections
FDA-SRSSpontaneous Reporting System Of The Food And Drug Administration
FDCFood, Drug, & Cosmetic
FDCFixed Dose Combination
FDCAFederal Food, Drug, And Cosmetic Act Of 1938
FEFOFirst Expiry First Out
FEIFacility Establishment Identifier
FFDCAFederal Food, Drug, And Cosmetic Act Of 1938
FGFinished Goods
FIFOFirst In First Out
FMEAFailure Modes And Effect Analysis
FMECAFailure Modes Effects And Criticality Analysis
FOIFreedom Of Information
FOIAFreedom Of Information Act
FRFederal Register
FTAFault Tree Analysis
FULFederal Upper Limit
GAMPGood Automated Manufacturing Practice
GAMPGood Automated Manufacturing Practice
GARRGrants Application Review Request
GCGas Chromatography
GCLPGood Clinical Laboratory Practice
GCLPGood Clinical Laboratory Practice
GCPGood Clinical Practice
GDPGood Documentation Practice
GDPGood Distribution Practice
GEOGenetically Engineered Organism
GEPGood Engineering Practice
GGPGood Guidance Practice
GITGastrointestinal Tract
GLPGood Laboratory Practice
GMOGenetically Modified Organism
GMPGood Manufacturing Practice
GPTGrowth Promotion Test
GRASGenerally Recognized As Safe
GRAS/EGenerally Recognized As Safe And Effective
GRPGood Review Practice
GTPGood Tissue Practice
GUDUFAGeneric Drug User Fee Amendments
GxPGood Practices
HACCPHazard Analysis Critical Control Point
HCIHuman-Computer Interaction
HCPHost Cell Proteins
HCPCSHealthcare Common Procedure Coding System
HDPEHigh Density Polyethylene
HEPAHigh Efficiency Particulate Air Filters
ULPAUltra-Low Particulate Air
HETPHeight Equivalent To The Theoretical Plate
HMEHot Melt Extrusion
HMIHuman Machine Interface
HPAPIHigh Potency API
HPLCHigh Performance Liquid Chromatography
HSAHealth Sciences Authority, Singapore
HVACHeating, Ventilating, And Air Conditioning
ICAHInternational Council On Harmonisation (Formally Known As International Conference On Harmonisation)
ICHInternational Council For Harmonisation
IDMCIndependent Data Monitoring Committee
IgIimmunoglobulins
IHIn House
IMIntramuscular
INDInvestigational New Drug
INDAInvestigational New Drug Application
INNInternational Nonproprietary Name
IPIntellectual Property
IPIndian Pharmacopeia
IPAIsopropyl Alcohol
IPCIn Process Control
IPCSInternational Programme On Chemical Safety (Who)
IPECInternational Pharmaceutical Excipients Council
IQInstallation Qualification
IQInstallation Qualification
IRInformation Request (Letter)
IRImmediate Release
IRBInstitutional Review Board
ISOInternational Organization For Standardization
ISPEInternational Society For Pharmaceutical Engineering
IUPACInternational Union Of Pure And Applied Chemistry
IVIntravenous
JPJapanese Pharmacopoeia
kGyKilogray: A Unit Of Irradiation Administered To A Drug Or Raw Material From A Cobalt-60
KOSKnowledge Organization System
KPPKey Process Parameter
LAFLaminar Air Flow
LALLimulus Amoebocyte Lysate
LANLocal Area Network
LC/GCLiquid Chromatography/Gas Chromatography
LDLethal Dose
LD50Lethal Dose Where 50% Of The Animal Population Die
LDPELow Density Polyethylene
LIMSLaboratory Instrument Management Systems
LIMSLaboratory Information Management System
LIRLaboratory Investigation Report
LOALetter Of Authorization
LODLimit Of Detection
LODLoss On Drying
LOQLimit Of Quantification
LRLaboratory Reagent
LVPLarge Volume Parenteral
LVPsLarge Volume Parenterals
MAMarketing Authorisation
MAAMarketing Authorisation Application
MabMonoclonal Antibody
MACMaximum Allowable Carryover
MAHMarketing Authorisation Holder
MDAMedical Devices Agency (UK)
MDDMaximum Daily Dose
MDIMetered Dose Inhaler
MDRMedical Device Reporting
MDUFMAMedical Device User Fee And Modernization Act Of 2002
MDUFSAMedical Device User Fee Stabilization Act Of 2005
MEDSAFEMedicines And Medicinal Devices Safety Authority (New Zealand)
MFRMaster Formula Record
MHRAMedicines And Healthcare Products Regulatory Agency (UK)
MLDMinimum Lethal Dose
MOAMethod Of Analysis
MOUMemorandum of Understanding
MRAMutual Recognition Agreement
MRSAMethicillin Resistant Staphylococcus Aureus
MSMass Spectroscopy
MSDSMaterial Safety Data Sheets
MTDMaximum Tolerated Dose
NAINo Action Indicated
NBENew Biologic Entity
NCENew Chemical Entity
NCRNon-Conformance Report
NDANew Drug Application
NDCNational Drug Code (Fda)
NFNational Formulary
NIRNear Infra Red Spectroscopy
NIRSNear Infrared Spectroscopy
NMENew Molecular Entity
NMRNuclear Magnetic Resonance Spectroscopy
NMTNot More Than
NOAELNo Observable Adverse Effect Level
NOCNotice Of Compliance (Canada)
NODNotice Of Deficiency (Canada
NONNotice Of Non-Compliance (Canada)
NRxNew Prescriptions
NSAIDNon-Steroidal Anti-Inflammatory Drug
OAIOfficial Action Indicated
ODIOrally Disintegrating Tablet
OELOccupational Exposure Level
OOSOut Of Specification
OOTOut Of Trend
OQOperation Qualification
OSDOral Solid Dosage
OSHAOccupational Safety And Health Administration
OTCOver-The-Counter Drugs
PACPost-Approval Changes
PACTPost-Approval Commitment Tracking
PAIPre-Approval Inspection
PAIPre-Approval Inspection
PAOPoly Alpha Olefin
PASPrior Approval Supplement
PATProcess Analytical Technologies
PATProcess Analytical Technology
PDPharmacodynamics
PDAParenteral Drug Association
PDEPermitted Daily Exposure
PDUFAPrescription Drug User Fee Act
PEPFARPresidential Emergency Plan For Aids Relief
PETPreservative Efficacy Test
Ph.Eur.Pharmacopeia Europa
PIC/SPharmaceutical Inspection Co-Operation Scheme
PILPatient Information Leaflet
PKPharmacokinetics
PLAProduct License Application (CBER)
PLAIRPre-Launch Activities Importation Request (USFDA)
PLCProgrammable Logic Control
PMAPremarket Approval
PMFPublic Master File
PMPPlant-Made Pharmaceutical
PMSPostmarketing Surveillance
POMPrescription-Only Medicine (UK)
ppbParts Per Billion
PPEPersonal Protective Equipment
PPIPatient Package Insert
ppmParts Per Million
PPMPlanned Preventive Maintenance
PPQProcess Performance Qualification
PQPerformance Qualification
PQGPharmaceutical Quality Group
PUDUFAPrescription Drug User Fee Act (FDA)
PVProcess Validation
PVCPolyvinyl Chloride
PVDCPolyvinylidene Chloride
PWPurified Water
QAQuality Assurance
QbDQuality By Design
QbRQuestion-Based Review
QCQuality Control
QDOnce Daily
QIDFour Times A Day
QMQuality Manual
QMSQuality Management System
QODEvery Other Day
QoSQuality Overall Summary
QPQualified Person (EU)
QRMQuality Risk Management
QSDQuality System Dossier
QSMQuality System Management
QUQuality Unit
R&DResearch And Development
RARegulatory Affairs
RCRRisk Control Review
REMSRisk Evaluation And Mitigation Strategy
RFIRequest For Information
RHRelative Humidity
RLAFReverse Laminar Air Flow
RLDReference Listed Drug
RMRaw Material
RMSReference Member State (Europe)
RNARibonucleic Acid.
ROReverse Osmosis
ROPPRoll On Pilfer Proof
RSRelated Substance
RTRRefuse To Receive
RxPrescription
SAESerious Adverse Event
SALSterility Assurance Level
SARStructure-Activity Relationship.…
SATSite Acceptance Test
SDDSpray Dried Dispersion
SDNScreening Deficiency Notice (Canada)
SEDDSSelf Emulsifying Drug Delivery System
SEMScanning Electron Microscopy
SFCSupercritical Fluid Chromatography
SHPRASouth African Health Products Authority [Formally Known As Medicines Control Council (MCC)]
SIPSterilization In Lace/Steam In Place
SLSSodium Lauryl Sulphate
SMDSmall Molecule Drugs
SMESubject Matter Expert
SMEPACStandardized Measurement Of Particulate Airborne Concentration
SMFSite Master File
sNDASupplemental New Drug Application.…
SNPSingle Nucleotide Polymorphism
SOPStandard Operating Procedure
SPESociety For Pharmaceutical Engineering
SPRStructure-Property Relationship
STDSexually Transmitted Disease
SUBSingle Use Bioreactor
SUPACScale-Up And Post Approval Changes
SUSSingle-Use System
SVPSmall Volume Parenteral
TCThermocouple
TDITolerable Daily Intake
TDSTotal Dissolved Solids
TETherapeutic Equivalence
TGATherapeutics Goods Administration (Australia)
TIDThree Times A Day
TLCThin Layer Chromatography
TOCTotal Organic Carbon
TPPTarget Product Profile
TSETransmissible Spongiform Encephalopathy
UDIUnique Device Identification
UNIIUnique Ingredient Identifier
URSUser Requirement Specification
USFDAUnited States Foods And Drugs Administration
USPUnited States Pharmacopeia
USPCU.S. Pharmacopeial Convention
USP-NFUnited States Pharmacopeia-National Formulary
UTIUrinary Tract Infection
VAIVoluntary Action Indicated
VMPValidation Master Plan
WFIWater For Injection
WFIWater For Injection
WHOWorld Health Organisation
WLWarning Letter
XPSX-Ray Photoelectron Spectroscopy
505 (b) (2) submissionA 505(B)(2) Application Is A New Drug Application (NDA) Described In Section 505(B)(2) Of The Act

The Pill Book (15th Edition)

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