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
AADA | Abbreviated Antibiotic Drug Application |
AAO | American Academy Of Ophthalmology |
ABLA | Abbreviated Biologics License Application |
ADCs | Antibody-Drug Conjugates |
ADE | Adverse Drug Event |
ADI | Acceptable Daily Intake |
ADME | Absorption, Distribution, Metabolism, And Excretion |
ADR | Adverse Drug Reaction |
ADRS | Adverse Drug Reporting System |
AE | Adverse Event |
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 |
AMP | Average Manufacturer Price |
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. Also Referred To As “Active 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, Refrigeration And Air Conditioning Engineers |
ASM | Active Substance Manufacturer |
ASME | American Society Of Mechanical Engineers |
ASMF | Active Substance Master File |
ASP | Average Sales Price. |
ASQ | American Society For Quality |
AST | Accelerated Stability Testing |
ASTM | American Society For Testing And Materials |
AWP | Average Wholesale Price |
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 |
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 |
BPCIA | Biologics Price Competition And Innovation Act (2009) |
BPR | Batch Packaging Record |
BRMS | Biologics Regulatory Management System |
BSA | Body Surface Area |
BSE | Bovine Spongiform Encephalopathy |
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 |
CANDA | Computer Assisted New Drug Application |
CAPA | Corrective Action And Preventive Action |
CAPLA | Computer Assisted Product License Application |
CAS | Chemical Abstracts Service |
CBE | Changes Being Effected |
CBER | Center For Biologics Evaluation And Research |
CCIT | Container Closure Integrity Test |
CDER | Center For Drug Evaluation And Research |
CDRH | Center For Devices And Radiological Health |
CDSCO | Central Drug Standard Control Organization (India) |
CEP | Certification Of Suitability Of European Pharmacopoeia Monographs |
CFR | Code Of Federal Regulations |
CFU | Colony Forming Unit |
cGMP | Current Good Manufacturing Practices |
CHO | Chinese Hamster Ovaries |
CIP | Clean In Place |
CIP | Clean In Place |
CJD | Creutzfeldt Jakob Disease |
CMC | Chemistry, Manufacturing And Controls |
CMO | Contract Manufacturing Organization |
CMS | Centers For Medicare And Medicaid Services |
CNS | Central Nervous System |
COA | Certificate Of Analysis |
COC | Certificate Of Conformance/ Compliance |
COI | Conflict Of Interest |
COP | Clean Out Of Place |
COPP | Certificate Of Pharmaceutical Products |
CoS | Certificate Of Suitability |
CPI | Consumer Price Index |
CPP | Critical Process Parameter |
CPV | Continued Process Verification |
CQA | Critical Quality Attribute |
CR | Child Resistant |
CRF | Case Report Form |
CRL | 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) |
DAW | Dispense As Written |
DDS | Drug Delivery Systems |
DGCI | Drug Controller General Of India |
DI | Deionized Water |
DIN | Drug Identification Number (Canada) |
DMF | Drug Master File |
DNA | Deoxyribonucleic Acid |
DOA | Drugs Of Abuse |
DOE | Design Of Experiment |
DOP | Dioctyl Phthalate |
DP | Drug Product |
DPC-PTR Act | Drug Price Competition And Patent Trade Restoration Act Of 1984 |
DPI | Dry Powder Inhaler |
DQ | Design Qualification |
DS | Drug Substance |
DSMB | Clinical Trials Data And Safety Monitoring Board |
DTC | Direct To Consumer Advertising |
DUNS | Data Universal Numbering System |
EAC | Estimated Acquisition Cost |
EC | European Community |
ECTD | Electronic Common Technical Document, |
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 |
EHS | Environmental Health And Safety |
EIA | Enzyme Immunoassay |
EIR | Establishment Inspection Report |
EMA | European Medicines Agency (Formerly European Medicines Evaluation Agency -EMEA) |
EP | European Pharmacopoeia |
EPAR | European Public Assessment Reports (EMEA) |
EPO | Erythropoietin |
EPS | Expanded Polystyrene |
ERP | Emergency Response Plan |
ERS | Electronic Regulatory Submission |
ERSR | Electronic Regulatory Submissions And Review |
ESCA | Electron Spectroscopy For Chemical Analysis |
ESG | Electronic Submissions Gateway |
ETP | Effluent Treatment Plant |
EU | Endotoxin Unit |
EU | European Union |
FAB | An Antibody Fragment That Contains The Regions That Bind To Antigens |
FAI | Further Action Indicated |
FAR | Field Alert Report |
FAT | Factory Acceptance Testing |
FBD | Fluid-Bed Dryer |
FDA Form 482 | FDA Form For Notice Of Inspection |
FDA | Us Food And Drug Administration |
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 |
FEFO | First Expiry First Out |
FEI | Facility Establishment Identifier |
FFDCA | Federal Food, Drug, And Cosmetic Act Of 1938 |
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 |
FUL | Federal Upper Limit |
GAMP | Good Automated Manufacturing Practice |
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 Documentation 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 |
GTP | Good Tissue Practice |
GUDUFA | Generic Drug User Fee Amendments |
GxP | Good Practices |
HACCP | Hazard Analysis Critical Control Point |
HCI | Human-Computer Interaction |
HCP | Host Cell Proteins |
HCPCS | Healthcare Common Procedure Coding System |
HDPE | High Density Polyethylene |
HEPA | High Efficiency Particulate Air Filters |
ULPA | Ultra-Low Particulate Air |
HETP | Height Equivalent To The Theoretical Plate |
HME | Hot Melt Extrusion |
HMI | Human Machine Interface |
HPAPI | High Potency API |
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) |
ICH | International Council For Harmonisation |
IDMC | Independent Data Monitoring Committee |
Ig | Iimmunoglobulins |
IH | In House |
IM | Intramuscular |
IND | Investigational New Drug |
INDA | Investigational New Drug Application |
INN | International Nonproprietary Name |
IP | Intellectual Property |
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 |
IQ | Installation Qualification |
IR | Information Request (Letter) |
IR | Immediate Release |
IRB | Institutional Review Board |
ISO | International Organization For Standardization |
ISPE | International Society For Pharmaceutical Engineering |
IUPAC | International Union Of Pure And Applied Chemistry |
IV | Intravenous |
JP | Japanese Pharmacopoeia |
kGy | Kilogray: A Unit Of Irradiation Administered To A Drug Or Raw Material From A Cobalt-60 |
KOS | Knowledge Organization System |
KPP | Key Process Parameter |
LAF | Laminar Air Flow |
LAL | Limulus Amoebocyte Lysate |
LAN | Local Area Network |
LC/GC | Liquid Chromatography/Gas Chromatography |
LD | Lethal Dose |
LD50 | Lethal Dose Where 50% Of The Animal Population Die |
LDPE | Low Density Polyethylene |
LIMS | Laboratory Instrument Management Systems |
LIMS | Laboratory Information Management System |
LIR | Laboratory Investigation Report |
LOA | Letter Of Authorization |
LOD | Limit Of Detection |
LOD | Loss On Drying |
LOQ | Limit Of Quantification |
LR | Laboratory Reagent |
LVP | Large Volume Parenteral |
LVPs | Large Volume Parenterals |
MA | Marketing Authorisation |
MAA | Marketing Authorisation Application |
Mab | Monoclonal Antibody |
MAC | Maximum Allowable Carryover |
MAH | Marketing Authorisation Holder |
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 |
MEDSAFE | Medicines And Medicinal Devices Safety Authority (New Zealand) |
MFR | Master Formula Record |
MHRA | Medicines And Healthcare Products Regulatory Agency (UK) |
MLD | Minimum Lethal Dose |
MOA | Method Of Analysis |
MOU | Memorandum of Understanding |
MRA | Mutual Recognition Agreement |
MRSA | Methicillin Resistant Staphylococcus Aureus |
MS | Mass Spectroscopy |
MSDS | Material Safety Data Sheets |
MTD | Maximum Tolerated Dose |
NAI | No Action Indicated |
NBE | New Biologic Entity |
NCE | New Chemical Entity |
NCR | Non-Conformance Report |
NDA | New Drug Application |
NDC | National Drug Code (Fda) |
NF | National Formulary |
NIR | Near Infra Red Spectroscopy |
NIRS | Near Infrared 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) |
NRx | New Prescriptions |
NSAID | Non-Steroidal Anti-Inflammatory Drug |
OAI | Official Action Indicated |
ODI | Orally Disintegrating Tablet |
OEL | Occupational Exposure Level |
OOS | Out Of Specification |
OOT | Out Of Trend |
OQ | Operation Qualification |
OSD | Oral Solid Dosage |
OSHA | Occupational Safety And Health Administration |
OTC | Over-The-Counter Drugs |
PAC | Post-Approval Changes |
PACT | Post-Approval Commitment Tracking |
PAI | Pre-Approval Inspection |
PAI | Pre-Approval Inspection |
PAO | Poly Alpha Olefin |
PAS | Prior Approval Supplement |
PAT | Process Analytical Technologies |
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 |
Ph.Eur. | Pharmacopeia Europa |
PIC/S | Pharmaceutical Inspection Co-Operation Scheme |
PIL | Patient Information Leaflet |
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 |
PMP | Plant-Made Pharmaceutical |
PMS | Postmarketing Surveillance |
POM | Prescription-Only Medicine (UK) |
ppb | Parts Per Billion |
PPE | Personal Protective Equipment |
PPI | Patient Package Insert |
ppm | Parts Per Million |
PPM | Planned Preventive Maintenance |
PPQ | Process Performance Qualification |
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 |
QbD | Quality By Design |
QbR | Question-Based Review |
QC | Quality Control |
QD | Once Daily |
QID | Four Times A Day |
QM | Quality Manual |
QMS | Quality Management System |
QOD | Every Other Day |
QoS | Quality Overall Summary |
QP | Qualified Person (EU) |
QRM | Quality Risk Management |
QSD | Quality System Dossier |
QSM | Quality System Management |
QU | Quality Unit |
R&D | Research And Development |
RA | Regulatory Affairs |
RCR | Risk Control Review |
REMS | Risk Evaluation And Mitigation Strategy |
RFI | Request For Information |
RH | Relative Humidity |
RLAF | Reverse Laminar Air Flow |
RLD | Reference Listed Drug |
RM | Raw Material |
RMS | Reference Member State (Europe) |
RNA | Ribonucleic Acid. |
RO | Reverse Osmosis |
ROPP | Roll On Pilfer Proof |
RS | Related Substance |
RTR | Refuse To Receive |
Rx | Prescription |
SAE | Serious Adverse Event |
SAL | Sterility Assurance Level |
SAR | Structure-Activity Relationship.… |
SAT | Site Acceptance Test |
SDD | Spray Dried Dispersion |
SDN | Screening Deficiency Notice (Canada) |
SEDDS | Self Emulsifying Drug Delivery System |
SEM | Scanning Electron Microscopy |
SFC | Supercritical Fluid Chromatography |
SHPRA | South African Health Products Authority [Formally Known As Medicines Control Council (MCC)] |
SIP | Sterilization In Lace/Steam In Place |
SLS | Sodium Lauryl Sulphate |
SMD | Small Molecule Drugs |
SME | Subject Matter Expert |
SMEPAC | Standardized Measurement Of Particulate Airborne Concentration |
SMF | Site Master File |
sNDA | Supplemental New Drug Application.… |
SNP | Single Nucleotide Polymorphism |
SOP | Standard Operating Procedure |
SPE | Society For Pharmaceutical Engineering |
SPR | Structure-Property Relationship |
STD | Sexually Transmitted Disease |
SUB | Single Use Bioreactor |
SUPAC | Scale-Up And Post Approval Changes |
SUS | Single-Use System |
SVP | Small Volume Parenteral |
TC | Thermocouple |
TDI | Tolerable Daily Intake |
TDS | Total Dissolved Solids |
TE | Therapeutic Equivalence |
TGA | Therapeutics Goods Administration (Australia) |
TID | Three Times A Day |
TLC | Thin Layer Chromatography |
TOC | Total Organic Carbon |
TPP | Target Product Profile |
TSE | Transmissible Spongiform Encephalopathy |
UDI | Unique Device Identification |
UNII | Unique Ingredient Identifier |
URS | User Requirement Specification |
USFDA | United States Foods And Drugs Administration |
USP | United States Pharmacopeia |
USPC | U.S. Pharmacopeial Convention |
USP-NF | United States Pharmacopeia-National Formulary |
UTI | Urinary Tract Infection |
VAI | Voluntary Action Indicated |
VMP | Validation Master Plan |
WFI | Water For Injection |
WFI | Water For Injection |
WHO | World Health Organisation |
WL | Warning Letter |
XPS | X-Ray Photoelectron Spectroscopy |
505 (b) (2) submission | A 505(B)(2) Application Is A New Drug Application (NDA) Described In Section 505(B)(2) Of The Act |