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.
Table of Contents
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.
| AADA | Abbreviated Antibiotic Drug Application |
| AAO | American Academy of Ophthalmology |
| ADE | Adverse Drug Effects |
| ADME | Absorption Distribution Metabolism Excretion |
| ADI | Acceptable Daily Intake |
| ADR | Adverse Drug Reactions |
| ADRS | Adverse Drug Reporting System |
| AGDUFA | Animal Generic Drug User Fee Act |
| AHU | Air Handling Unit |
| ALCOA | Acronym Referring to Acceptable, Ligible, Contemporaneous, Original and Accurate |
| ALCOA+ | Acronym Referring to Acceptable, Ligible, Contemporaneous, Original and Accurate, Complete Consistent, Enduring and Available |
| AME | Absorption, Metabolism and Excretion |
| ANDA | Abbreviated New Drug Application |
| ANOVA | Analysis of Vacience |
| ANVISA | Agencia Nacional De Vigilancia Sanitoria [National Health Surveillance Agency, Brazil] |
| AP | Applicants Part |
| API | Active Pharmaceutical Ingredients |
| APIC | Active Pharmaceutical Ingredients Comitee |
| AQL | Acceptable Quality Level |
| APR | Annual Products Report |
| AR | Analytical Reagents |
| ARB | Angiotensin Receptor Blockers |
| ASM | Active Substance Manufacturer |
| ASMF | Active Substance Master File |
| ASTM | American Society For Testing and Materials |
| AST | Accelerated Stability Testing |
| BA | Bio Availability |
| BE | Bio Equivalence |
| BET | Bacterial Endotoxin Test |
| BFS | Blow Fill Seal |
| BI | Biological Indication |
| BIND | Biological Investigational New Drug |
| BLA | Biologics Licence Application |
| BMI | Body Mass Index |
| BMR | Batch Manufacturing Record |
| BOM | Bill of Materials |
| BOPP | Bio-oxially Oriented Poly Propylene |
| BP | British Pharmacopoeia |
| BPR | Batch Packaging Record |
| BPC | Bulk Pharmaceutical Chemical |
| BRMS | Biologics Regulatory Management System |
| BSA | Body Surface Area |
| BSE | Bovine Spongiform Encephalopathy |
| BsUFA | Biosimilar User Fee Act |
| BSI | British Standard Institute |
| BTD | Breakthrough Therapy Destination |
| BVC | British Veterinary Codex |
| BOD | Biological Oxygen Demand |
| CA | Chemical Abstracts |
| CAPA | Corrective and Preventive Action |
| CANDA | Computer Assisted New Drug Application |
| CAPLA | Computer Assisted Product Licence Application |
| CAS | Chemical Abstracts Service |
| CDSCO | Central Drug Standard Control Organization |
| CFR | Code of Federal Regulation |
| CFU | Colony Forming Unit |
| CGMP | Current Good Manufacturing Practices |
| CMO | Contract Manufacturing Organization |
| CMS | Continuous Monitoring System |
| COA | Certificate of Analysis |
| COP | Clean Out of Place |
| COPP | Certificate of Pharmaceutical Product |
| COS | Certificate of Suitability |
| CPI | Consumer Price Index |
| CPP | Critical Process Parameter |
| CRO | Contract Research Organization |
| CRS | Contamination Response System |
| CQA | Critical Quality Attribute |
| CT | Clinical Trials |
| CTD | Common Technical Documents |
| CVMP | Commitee on Veterinary Medical Products |
| COD | Chemical Oxygen Demand |
| DIW | De Ionised Water |
| DIN | Drug Identification Number |
| DP | Drug Products |
| DI | Data Integrity |
| DOA | Drugs of Abuse |
| DOE | Design of Experiments |
| DOP | Dioctyl Phthalate |
| DPI | Dry Powder Injection |
| DQ | Design Qualification |
| DS | Drug Substance |
| EC | European Commitee |
| ED | Effective Dose |
| EDMF | European Drug Master File |
| EDQM | European Directorate for the Quality of Medicine |
| EFPIA | European Federation of Pharmaceutical Industries and Association |
| EFTA | European Free Trade Association |
| EIA | Enzyme Immuno Assay |
| EIR | Establishment Inspection Report |
| EMA | European Medicine Agency |
| EP | European Pharmacopoeia |
| EPAR | European Public Assessment Report |
| EPS | Expanded Poly Styrene |
| ERP | Enterprise Resource Planning |
| ETP | Effluent Treatment Plant |
| EU | Endotoxin Unit |
| FAI | Further Action Indicated |
| FAR | Field Alert Report |
| FAT | Factoey Acceptance Report |
| FDA | Food and Drug Administration |
| FDC | Fixed Dose Combination |
| FEFO | First Expiry First Out |
| FEI | Facility Establishment Identifier |
| FBD | Fluid Bed Dryer |
| FG | Finished Goods |
| FGTN | Finished Goods Transfer Note |
| FIFO | First In First Out |
| FOI | Freedom of Information |
| FR | Federal Register |
| FTA | Fault Tree Analysis |
| GC | Gas Chromatography |
| GCLP | Good Clinical Laboratory Practices |
| GLP | Good Laboratory Practices |
| GIT | Gastro Intestinal Tract |
| GMO | Genetically Modified Organisms |
| GMP | Good Manufacturing Practices |
| GDP | Good Documentation Practices |
| GHP | Good Housekeeping Practices |
| GPT | Growth Promotion Test |
| GRP | Good Review Practices |
| HACCP | Hazard Analysis Critical Control Point |
| HCI | Human Computer Interface |
| HDPE | High Density Polyethylene |
| HEPA | High Efficiency Particulate Air |
| HMI | Human Machine Interface |
| HPLC | High Performance Liquid Chromatography |
| HSA | Health Sciences Authority |
| HVAC | Heating Ventilation Air Condition |
| ICH | International Council For Harmonization |
| IND | Investigational New Drugs |
| INDA | Investigational New Drug Application |
| INN | International Nani proprietary Name |
| IM | Intra Muscular |
| IP | Indian Pharmacopoeia |
| IPA | Iso Propyl Alcohol |
| IV | Intra Venous |
| IPCS | International Programme On Chemical Safety |
| IPEC | International Pharmaceutical Excipients Councils |
| IPC | In Process Product Container |
| IPC | In Process Control |
| IQ | Installation Qualification |
| IR | Immediate Release |
| ISO | International Organisations For Organization |
| ISPE | International Society For Pharmaceutical Engineering |
| IUPAC | International Union of Pure and Applied Chemistry |
| JP | Japanese Pharmacopoeia |
| JAJ | Johnson & Johnson Inc |
| KOS | Knowledge Organization System |
| KFT | Karl Fisher Titration |
| LAL | Limulus Amoebocyte Lysate |
| LAN | Local Area Network |
| LAF | Laminar Air Flow |
| LD | Lethal Dose |
| LDPE | Low Density Polyethylene |
| LIMS | Laboratory Management System |
| LIR | Laboratory Investigation Report |
| LOD | Loss On Drying |
| LOD | Limit of Detection |
| LOA | Letter if Agreement |
| LOA | Letter of Authorization |
| LOQ | Limit of Quantification |
| LR | Laboratory Reagents |
| LVPs | Large Volume Parenterals |
| MAC | Maximum Allowable Carryover |
| MAH | Marketing Authorization Holder |
| MDI | Metered Dose Inhaler |
| MDD | Maximum Daily Dose |
| MDR | Medical Device Reporting |
| MEDSAFE | Medicines and Medicinal Devices Safety Authority |
| MHRA | Medicines and Healthcare Products Regulatory Agency |
| MLD | Minimum Lethal Dose |
| MOA | Method of Analysis |
| MFR | Master Formula Record |
| MRP | Maximum Retail Price |
| MS | Mass Spectroscopy |
| MSDS | Materials Safety Data Sheet |
| MTD | Maximum Tolerated Dose |
| NCE | New Chemical Entity |
| NAI | Non Action Indicated |
| NCR | Non Conformance Report |
| NDA | New Drug Application |
| NDC | National Drug Code |
| NF | National Formulary |
| NIR | Near Infrared Spectroscopy |
| NME | New Molecular Entity |
| NMR | Nuclear Magnetic Resonance Spectroscopy |
| NMT | Not More Than |
| NOC | Notice of Compliance |
| NOD | Notice of Deficiency |
| NON | Notice of Non-compliance |
| NSAID | Non-Steroidal Anti Inflammatory Drug |
| OAI | Official Action Indicated |
| ODI | Orally Disintegrating Tablets |
| OEL | Occupational Exposure Level |
| OQ | Operational Qualification |
| OSD | Oral Solid Dosage |
| OSHA | Occupational Safety and Health Administration |
| OOS | Out of Specifications |
| OOT | Out Of Trend |
| OTC | Over The Counter |
| PAC | Post Approval Changes |
| PACT | Post Approval Commitment Tracking |
| PAI | Pre Approval Inspection |
| PAO | Poly Alpha Olefin |
| PAS | Prior Approval Supplement |
| PAT | Process Analytical Technology |
| PD | Pharmacodynamics |
| PDA | Parenteral Drug Association |
| PK | Pharmacokinetics |
| PLA | Product Licence Application |
| PLC | Programmable Logic Control |
| PMS | Post Marketting Surveillance |
| PMD | Product Management Department |
| POM | Prescription Only Medicines |
| PPB | Parts Per Billion |
| PPE | Personal Protective Equipment |
| PPM | Parts Per Million |
| PPT | Personal Protective Transfer |
| PV | Process Validation |
| PVC | Poly Vinyl Chloride |
| PVDC | Poly Vinyl Di Chloride |
| PW | Purified Water |
| QA | Quality Assurance |
| QC | Quality Control |
| QbD | Quality By Design |
| QM | Quality Manual |
| QMS | Quality Management System |
| QP | Qualified Person |
| QRM | Quality Risk Management |
| QSD | Quality System Dossier |
| QSM | Quality System Management |
| QU | Quality Unit |
| RCR | Risk Control Review |
| R & D | Research and Development |
| RLAF | Reverse Laminar Air Flow |
| RLD | Reference Listen Drug |
| RH | Relative Humidity |
| RM | Raw Materials |
| RS | Related Substance |
| RMS | Raw Materials Store |
| RMG | Rapid Mixer Granulator |
| RTR | Refuse To Receive |
| SAL | Sterility Assurance Level |
| SAT | Site Acceptance Test |
| SIP | Steam In Place |
| SME | Subject Matter Expert |
| SMF | Site Master File |
| SPM | Secondary Packaging Materials |
| SLS | Sodium Lauryl Sulphate |
| SOP | Standard Operating Procedure |
| STD | Sexually Transmitted Disease |
| SUPAC | Scale-up and Post Approval Changes |
| SVP | Small Volume Parenteral |
| SWFI | Sterile Water For Injection |
| TC | Thermo Couple |
| TDI | Tolerable Daily Intake |
| TDS | Total Dissolved Solids |
| TGA | Therapeutic Goods Administration |
| TLC | Thin Layer Chromatography |
| TOC | Total Organic Carbon |
| TSE | Transmissible Spongiform Encephalopathy |
| USP | United State Pharmacopoeia |
| USPC | United States Pharmacopoeial Convention |
| USP-NF | United State Pharmacopoeia – National Formulatory |
| URS | User Requirements Specifications |
| USC | United State Code |
| UTD | Urinary Tract Infection |
| VAF | Virus Antibody Free |
| VTD | Vaccum Tray Dryer |
| VAI | Volumatory Action Indicated |
| VMP | Validation Master Plan |
| WBC | White Blood Cells |
| WC | Working Conformation |
| WDA | Wholesale Dealer’s Licence |
| WI | Working Instructions |
| WFI | Water For Injection |
| WOE | Waiting of Evidence |
| WHO | World Health Organization |
| WL | Warning 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 |
|---|---|
| Australia | Therapeutics Goods Administration (TGA) |
| Brazil | Agencia Nacional De Vigilancia Sanitoria (ANVISA) |
| Canada | Health Canada |
| China | State Food and Drug Administration |
| Costa Rica | Ministry of Health |
| Colombia | Ministry of Health |
| Denmark | Danish Medicines Agency (DMA) |
| Europe | European Medicines Agency (EMA) |
| Germany | Federal Institute For Medical Drugs and Devices |
| Hong Kong | Department of Health; Pharmaceutical Services |
| India | Central Drug Standard Control Organization (CDSCO) |
| Ireland | Irish Medicines Board (IMB) |
| Italy | Italian Pharmaceutical Agency (IPA) |
| Japan | Ministry of Health, Labour and Welfare |
| Kenya | Pharmacy Poison Board (PPB) |
| Malaysia | National Pharmaceutical Control Bureau, Ministry of Health |
| New Zealand | Medsafe, Medicines and Medical Devices Safety Authority |
| Netherlands | Medicines Evaluation Board (MEB) |
| Nigeria | National Agency For Food and Drug Administration and Control |
| Pakistan | Drugs Control Organization, Ministry of Health |
| Paraguay | Ministry of Health |
| Romania | Ministry of Health |
| Saudi Arabia | Ministry of Health |
| Sweden | Medical Products Agency (MPA) |
| South Africa | Medicines Control Council (MCC) |
| Sri Lanka | SPC, Ministry of Health |
| Switzerland | Swissmedic, Swiss Agency For Therapeutic Products |
| Singapore | Center for Pharmaceutical Administration Health Sciences Authority |
| Thailand | Ministry of Health |
| USA | Food and Drug Administration |
| UK | Medicines and Healthcare Products Regulatory Agency |
| Ukrain | Ministry of Health |
| Uganda | Uganda 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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