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 |
The Pill Book (15th Edition)
