An NSF International Company Jargon Buster - List of Abbreviations
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| Acronym | What it means |
|---|---|
| 483 | US Inspector’s list of observations, which are written on form FD483 at the end of an Inspection |
| 501k | FDA CDRH term for the registration/approval of low/medium risk Medical Devices (the number originates from the FD&C; Act). See also PMA |
| ACA | Agreement on Conformity Assessment and acceptance of industrial products |
| ACOLs | Acceptable Carry-Over Limits |
| ADI | Acceptable Daily Intake |
| ADME | Adsorption, Distribution, Metabolism and Excretion studies |
| ADR | Adverse Drug Reaction |
| AIM | Active Ingredient Manufacturer |
| ANDA | Abbreviated New Drug Application (FDA) |
| API | Active Pharmaceutical Ingredient often called Drug Substance |
| APR | Annual Product Review (US) – see also PQR (EU) |
| AR | Assessment Report – EU term a report from the assessment of the EU Marketing Authorisation |
| ASEAN | Association of SE Asian Nations (relating to Asian equivalent system to ICH CTD structure) |
| ASM | Active Substance Manufacturer (Drug Substance) |
| ASMF | Active Substance Master File (Drug Substance) |
| ASTM | American Society for Testing of Materials |
| ATC | Anatomical Therapeutic Code |
| BAN | British Approved Name |
| BfArM | German Regulatory Agency (Bundesinstitut fur Arzneimittel und Medizinprodukt) |
| BLA | Biologics Licence Application (FDA CBER) |
| BMF | Biologics Master File – Part of a BLA |
| BNF | British National Formulary |
| BoM | Bill of Materials (List of items on a computer MRP system eg items in a formulation/recipe) |
| BP | British Pharmacopoeia |
| BPC | British Pharmaceutical Codex |
| BPC | Bulk Pharmaceutical Chemical – US term which encompassed both active (API) and non-active substances (e.g. excipients) |
| BPDR | Biological Product Deviation Report (US 21 CFR 600.14) |
| BSE | Bovine Spongiform Encephalopathy (Mad Cow Disease) |
| Can | also be Manufacturing Authorisation (EU) |
| CAPA | Corrective and Preventative Actions |
| CAS | Chemical Abstracts Service (Journal) |
| CBE or CBE 30 | or CBE30 Changes Being Effected/Changes Being Effected 30 days (US – updates/variations to NDAs/ANDAs etc) See also PAS |
| CBER | Center for Biologics Evaluation and Research (FDA) |
| CD | Controlled Drug eg a narcotic such as Morphine |
| CDER | Center for Drug Evaluation and Research (FDA) |
| CDRH | Center for Devices and Radiological Health (FDA) |
| CE | Communitee Européen (EU mark of compliance) This is required to displayed on Medical Devices |
| CEC | Commission of the European Communities |
| CEFRIC | European Federation of Chemical Industries |
| CEN | Comité Européen de Normalisation (EU standards Committee) |
| CEP | Certificate of Suitability – of the European Pharmacocopeia |
| CFR | Code of Federal Regulations (USA) |
| CFUs | Colony Forming Unit(s) – microbiological measurement |
| cGMP | Current Good Manufacturing Practice (USA) |
| CHMP | Committee for Human Medicinal Products (EU) ws formerly known as CPMP |
| CIOMS | Council for International Organisations of Medical Sciences |
| CMC | Chemistry, Manufacturing and Controls – part of the old US format of an NDA, IND, ANDA etc |
| CMD(h) | Coordination Group for Mutual Recognition and Decentralised Procedures in the EU – Human medicinal products |
| CMS | Concerned Member State (EU) – in process of Mutual Recognition of National Marketing Authorisations within the EU, this would be the Member State that is being applied to |
| CoA | Certificate of Analysis |
| CoC | Certificate of Conformity |
| Cosmetlex | Compendium of Rules Governing Cosmetic Products (EU) |
| COSSH | Control of Substances Hazardous to Health – part of the UK laws on Health and Safety |
| Cp/Cpk | Process Capability Indices |
| CPMP | Committee for Proprietary Medicinal Products (EU) – old name for CHMP |
| CPPs | Critical Process Parameters |
| CPSC | Consumer Products Safety Commission (US) |
| CQA | Critical Quality Attributes |
| CSA | Certificate of Suitability Application (Ph Eur) |
| CSM | Committee on Safety of Medicines (UK) |
| CSO | Consumer Safety Officer (USA) |
| CT | Clinical Trial |
| CTA | Clinical Trial Application (EU) |
| CTC | Clinical Trial Certificate (UK – superseded by CTA) |
| CTD | Common Technical Document – ICH format for Marketing Authorisations |
| CTD | Clinical Trials Directive (2001/20/EC) |
| CTX | Clinical Trial Exemption (UK – superseded by CTA) |
| CVM | Committee for Veterinary Medicinal Products (EU) |
| CVMP | Center for Veterinary Medicines (FDA USA) |
| DAB | Deutsche Arzneibuch (German Pharmacopoeia) |
| DCP | Decentralised Procedure (EU Marketing Authorisations) |
| DEA | Drug Enforcement Agency (US – narcotics controls) |
| DG | Directorates Generales (EU – superseded by Departments) |
| DI | Deionised (purified) Water |
| DMF | Drug Master File |
| DMRC | Defective Medicines Reporting Centre – part of the UK MHRA |
| DoE | Design of Experiments |
| DoH | Department of Health (eg UK) |
| DP | Drug Product |
| DQ | Design Qualification |
| DS | Drug Substance |
| EC | European Community |
| ECJ | European Court of Justice |
| EDMF | European Drug Master File |
| EDMS | Electronic Document Management System |
| EDQM | European Department for Quality of Medicines and Healthcare (European Pharmacopoeia) |
| EEA | European Economic Area |
| EFPIA | European Federation of Pharmaceutical Industries Association |
| EFTA | European Free Trade Area (Association) |
| EIR | Establishment Inspection Report (USA) Outcome can be NAI, VAI or OAI |
| EMA | European Medicines Agency Note – this acronym is not generally used – see EMEA |
| EMEA | European Medicines Agency (previously the European Medicines Evaluation Agency, but this acronym continues to be used) |
| EP | European Parliament Sometimes (incorrectly) used for the European Pharmacopoeia (this has the official abbreviation Ph Eur) |
| EPAR | European Public Assessment Report |
| ER&S; | Electronic Records and Signatures |
| EU | European Union |
| EUDRA | European Union Drug Regulatory Affairs |
| EudraGMP | European Union Drug Regulatory Affairs Good Manufacturing Practice |
| Eudralex | Compendium of Rules Governing Medicinal Products (EU) |
| Eudranet | European Union Drug Regulatory Authorities Network |
| European | Pharmacopoeia (this has the official abbreviation Ph Eur) |
| EWG | Expert Working Group (EU) |
| FAR | Field Alert Report (US 21 CFR 314.81) |
| FAT | Factory Acceptance Test(ing) - See also SAT |
| FCC | Food and Chemical Codex |
| FD&C; | Food, Drug and Cosmetic Act (USA) |
| FDA | Food and Drug Administration (USA) |
| FDAMA | FDA Modernization Act (to update the FD&C; and PHS Acts) |
| FEFO | First Expired First Out |
| FIFO | First In First Out |
| FMEA | Failure Modes and Effect Analysis (Risk Analysis Technique) |
| FOI | Freedom of Information |
| FS | Federal Standard (USA) or Functional Specification (of a piece of equipment – links to URS) |
| FTC | Federal Trade Commission (USA) |
| GAMP | Good Automated Manufacturing Practices (ISPE Gudieline) |
| GCLP | Good Control Laboratory Practice |
| GCP | Good Clinical Practice |
| GDP | Good Distribution Practice |
| GLP | Good Laboratory Practice (Safety/Toxicology studies) |
| GMP | Good Manufacturing Practice |
| GRAS | Generally Recognized as Safe (USA) |
| GRP | Good Regulatory Practice |
| GSL | General Sales List (UK) |
| GxP | Good ‘x’ Practice = GMP, GAMP, GCLP, etc |
| HACCP | Hazard Analysis and Critical Control Points (a Risk Analysis technique) |
| HHS | US Department of Health and Human Services (The FDA reports into the HHS) |
| HPB | Health Protection Branch (Canada) – now Health Canada |
| HVAC | Heating Ventilation and Air Conditioning |
| IAG | Inspection Action Group (UK MHRA) |
| ICH | International Conference on Harmonisation (EU, Japan, USA) |
| IFPMA | International Federation of Pharmaceutical Manufacturers Associations |
| IKS | Switzerland Regulatory Authority |
| IMB | Irish Medicines Board |
| IMP | Investigational Medicinal Product (Clinical Trial Product – EU terminology for a CT drug product) |
| IMP-MLA | Manufacturing Licence Approval – Investigational Medicinal Products (EU) |
| IMPD | Investigational Medicinal Product Dossier (a sub-set of an EU CTA – Clinical Trial Application) |
| INCI | International Nomenclature of Cosmetic Ingredients |
| IND | Investigational New Drug (USA) |
| INN | International Non-proprietary Name |
| IPCs | In Process Controls |
| IPEC | International Pharmaceutical Excipients Council |
| IQ | Installation Qualification |
| IQA | Institute of Quality Assurance (UK) See also PQG |
| ISO | International Standards Organisation |
| ISPE | International Society of Pharmaceutical Engineers |
| IUPAC | International Union of Pure and Applied Chemistry |
| IV/IVTC | In-vivo/in-vitro correlation |
| IVDD | In vitro Diagnostic Medical Devices Directive |
| IWG | Inspectorate Working Group (EU) |
| JAN | Japanese Approved Name |
| JNDA | Japanese New Drug Application |
| JP | Japanese Pharmacopoeia |
| JPMA | Japanese Pharmaceutical Manufacturers Association |
| LAF | Laminar Air Flow |
| LOD | Limit of Detection |
| LOQ | Limit of Quantitation |
| MA | Marketing Authorisation (EU) |
| MAA | Marketing Authorisation Application (EU) |
| MAH | Marketing Authorisation Holder (EU) |
| MDA | Medical Devices Agency (now part of UK MHRA) |
| MDD | Medical Devices Directive (EU) |
| MDR | Medical Devices Regulations (EU) |
| MEDDEV | Medical Device Guidelines |
| MEDDRA | Medical Dictionary for Drug Regulatory Affairs |
| MHLW | Ministry of Health, Labour and Welfare (Japan see also PMDA) |
| MHRA | Medicines and Healthcare products Regulatory Agency |
| MIA | Manufacturer’s/Importer’s Authorisation |
| MIA(IMP) | Manufacturer’s Authorisation for investigational medicinal products (EU) |
| ML | Manufacturer’s Licence (UK old name for MIAs) |
| MoU | Memorandum of Understanding (US term for recognition of inspections with other countries) |
| MPA | Medicinal Products Agency (Sweden) |
| MR | Mutual Recognition (EU application route for Marketing Authorisations) see MRP also |
| MRA | Mutual Recognition Agreements (e.g. between the EU and other nations generally relating to Inspections) |
| MRFG | Mutual Recognition Facilitation Group (Now superseded by CMD(h) |
| MRI | Mutual Recognition Product Index |
| MRP | Mutual Recognition Procedure (EU) or Materials Resource Planning (eg computerised inventory planning) |
| MS | Manufacturer ‘Specials’ Licence (UK covering the manufacture of medicinal products which do not have an MAA) |
| NAI | No Action Indicated – US/FDA inspector’s recommendation following inspection (conclusion of the EIR) |
| NAIP | New Drug Approval Information Package (JP) |
| NAS | New Active Substance |
| NCE | New Chemical Entity |
| NDA | New Drug Application (USA) |
| NF | National Formulatory (USA generally published as part of the USP and called USP/NF) |
| NfG | EU – Notes for Guidance. These explain the standards required by the for products etc. For example Water for Pharmaceutical Use explains which Ph Eur grade of water that is expected to be used for processes and the formulation of products |
| OAI | Official Action Indicated: US/FDA inspector’s recommendation following inspection (conclusion of the EIR) ... bad news! |
| OIE | Office Internationale des Epizooties |
| OJ | Official Journal (European Union) |
| ONDQA | US FDA Office Of New Drug Chemistry Approach (reviewer group) see also PQAS |
| OOS | Out of Specification |
| OOT | Out of Trend |
| OPSR | Organisation for Pharmaceutical Safety and Research (Kiko – JP) |
| OQ | Operational Qualification |
| ORA | Office of Regulatory Affairs (USA) |
| OST | Ongoing Stability Testing |
| OTC | Over-the-Counter (available without prescription) |
| P | Pharmacy Only (EU labelling) |
| PA | Product Authorisation (Ireland) |
| PAD | Pharmaceutically Active Dose |
| PAI | Pre-Approval Inspection (UAS) |
| PAL | Pharmaceutical Affairs Law (Japan) |
| PAR | Proven Acceptable Range(s) |
| PAS | Prior Approval Supplement (US – update/variation to an an NDA, ANDA etc see also CBE) |
| PAT | Process Analytical Technology |
| PDA | Parenteral Drug Association (USA) |
| PDR | Physicians’ Desk reference (USA) |
| PERF | Pan-European Regulatory Forum |
| PFSB | Pharmaceutical and Food Safety Bureau (JP) |
| Ph Eur | Eur European Pharmacopoeia |
| Ph Fr | Fr Pharmacopée Francaise |
| PHS | Public Health Services Act (USA – biological products – see also FD&C;) |
| PhV | Pharmacovigilance sometimes abbreviated to PV |
| PIC/S | Pharmaceutical Inspection Convention or Pharmaceutical Inspection Convention Scheme |
| PIL | Patient Information Leaflet |
| PIL | Product Importation Licence (Japan) |
| PIP | Product Information Package (cosmetics) |
| PL | Product Licence (UK) |
| PLR | Product Licence Renewal |
| PMA | Pre-Market Approval – FDA CDRH term for the registration/approval of high risk Medical Devices (e.g. Heart Pacemakers) See also 510K |
| PMA/PhRMA | Pharmaceutical (Research and) Manufacturers Association (USA) |
| PMDA | Pharmaceutical and Medical Devices Agency (Japan – Marketing Authorisations, Inspections etc) |
| PMDEC | Pharmaceutical and Medical Devices Evaluation Center (JP) |
| PMF | Plant Master File (Alternative name for an Site Master File – mainly a US term) |
| POM | Prescription Only Medicine |
| PPQ | Process Performance Qualification (FDA Validation Guideline 2011) |
| PQ | Performance Qualification or Process Qualification |
| PQAS | US FDA Pharmaceutical Quality Assessment System (Reviewer group systems specialising in QbD applications) |
| PQG | Pharmaceutical Quality Group |
| PQR | Product Quality Review (EU) |
| PQS | Pharmaceutical Quality System |
| PV | Process Validation or sometimes used as an abbreviation for Phamacovigilance |
| PVAR | Provisional Variation Assessment Report (EU) |
| QA | Quality Assurance |
| QbD | Quality by Design |
| QC | Quality Control |
| QMS | Quality Management System |
| QP | Qualified Person (EU) |
| QWP | Quality Working Party (of the CHMP – EU) |
| RMS | Reference Member State (EU) |
| RO | Reverse Osmosis – a method of producing high quality water |
| RP | Responsible Person (Distribution within the EU) |
| SAT | Site Acceptance Test(ing) see also FAT |
| SBA | Summary Basic of Approval (USA) |
| See | also PAS |
| SI | Statutory Instrument (UK legislative tool) |
| SMF | Site Master File (EU term used in some member states) and was used in the USA for a DMF part 1 (now virtually obsolete) |
| SmPC | Summary of Product Characteristics (also SPC) EU: Medicinal Product |
| SNDA | Supplementary New Drug Application |
| SOP | Standard Operating Procedure |
| SPC | Statistical Process Control or Alternative term for a Summary of Product Characteristics |
| SWP | Safety Working Party |
| TFAN | Task Force for Accession Negotiations (EU) |
| TGA | Therapeutic Goods Agency (Australia) |
| TNTC | Too Numerous to Count (Microbiological term – often means bad news!!) |
| TOC | Total Organic Carbon |
| TSA | Therapeutic Substances Act |
| TSE | Transmissible Spongiform Encephalopathies |
| TVC | Total Viable Count |
| Type IA | Simple EU variation – not requiring notification other than through Annual Report |
| Type IAin | Simple EU variation – requiring immediate notification |
| USAN | United States Approved Name |
| USP/NF | United States Pharmacopoeia/National Formulary |
| VAI | Voluntary Action Indicated: US/FDA inspector’s recommendation following inspection (conclusion of the EIR). Here the Inspector feels that the company is carrying out appropriate corrective actions |
| VAMF | Vaccine Antigen Master File |
| VAR | Variation Assessment Report (EU) |
| WDIL | Wholesale Dealers’ Import Licence (UK) |
| WDL | Wholesale Dealer’s (General Sales List) Licence (UK) |
| WFI | Water for Injection |
| WHO | World Health Organisation |
| WL | Wholesale Dealers’ Licence (UK) |
| x /R chart | chart Mean and Range chart (an SPC tool) |
| XMF | Excipient Master File (EU) |
