<Jargon Blaster>
Jargon Buster
List of Abbreviations
| Acronym | What it means |
|---|---|
| 483 | US - Inspector's list of observations, which are written on form FD483 at the end of an Inspection |
| 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 |
| ASM | Active Substance Manufacturer (Drug Substance) |
| ASMF | Active Substance Master File (Drug Substance) |
| 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) |
| CAS | Chemical Abstracts Service (Journal) |
| CBE 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 |
| CHMP | Committee for Human Medicinal Products (EU) ws formerly known as CPMP |
| cGMP | Current Good Manufacturing Practice (USA) |
| 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) |
| CVMP | Committee for Veterinary Medicinal Products (EU) |
| 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 |
| DoH | Department of Health (eg UK) |
| DMF | Drug Master File |
| DMRC | Defective Medicines Reporting Centre - part of the UK MHRA |
| DoE | Design of Experiments |
| DP | Drug Product |
| DQ | Design Qualification |
| DS | Drug Substance |
| EC | European Community |
| ECJ | European Court of Justice |
| EDMF | European Drug Master File |
| 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) |
| 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
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
(EU database) |
| Eudralex | Compendium of Rules Governing Medicinal Products (EU) |
| Eudranet | European Union Drug Regulatory Authorities Network |
| EWG | Expert Working Group (EU) |
| FAR | Field Alert Report (US 21 CFR 314.81) |
| FAT | Factory Acceptance Test(ing) |
| FCC | Food and Chemical Codex |
| FDA | Food and Drug Administration (USA) |
| FD&C | Food, Drug and Cosmetic Act (USA) |
| FDAMA | FDA Modernization Act (to update the FD&C and PHS Acts) |
| FIFO | First In First Out |
| FMEA | Failure Modes and Effect Analyis |
| FOI | Freedom of Information |
| FS | Federal Standard (USA) |
| FTC | Federal Trade Commission (USA) |
| GAMP | Good Automated Manufacturing Practices |
| GCP | Good Clinical Practice |
| GCLP | Good Control Laboratory Practice |
| GDP | Good Distribution Practice |
| GLP | Good Laboratory Practice (Safety/Toxicology studies) |
| GMP | Good Manufacturing Practice |
| GxP | Good �x' Practice = GMP, GAMP, GCLP, etc |
| GRAS | Generally Recognized as Safe (USA) |
| GRP | Good Regulatory Practice |
| GSL | General Sales List (UK) |
| HACCP | Hazard Analysis and Critical Control Points (a Risk Analysis technique) |
| 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 |
| IND | Investigational New Drug (USA) |
| INN | International Nonproprietary Name |
| IMB | Irish Medicines Board |
| IMP | Investigational Medicinal Product (Clinical Trial Product - EU terminology for a CT drug product) |
| IMPD | Investigational Medicinal Product Dossier (a sub-set of an EU CTA - Clinical Trial Application) |
| IMP-MLA | Manufacturing Licence Approval - Investigational Medicinal Products |
| INCI | International Nomenclature of Cosmetic Ingredients |
| INN | International Non-proprietary Name |
| IPCs | In Process Controls |
| IQ | Installation Qualification |
| IQA | Institute of Quality Assurance (UK) |
| ISPE | International Society of Pharmaceutical Engineers |
| ISO | International Standards Organisation |
| 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)
Can also be Manufacturing 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 |
| MHRA | Medicines and Healthcare products Regulatory Agency |
| MHLW | Ministry of Health, Labour and Welfare (Japan see also PMDA) |
| MIA | Manufacturer's/Importer's Authorisation |
| MIA(IMP) | Manufacturer's Authorisation for investigational medicinal products |
| 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 |
| MRI | Mutual Recognition Product Index |
| 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) |
| 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) |
| 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) |
| OIE | Office Internationale des Epizooties |
| OJ | Official Journal (European Union) |
| 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) |
| 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 | European Pharmacopoeia |
| Ph Fr | Pharmacopée Francaise |
| PhV | Pharmacovigilance sometimes abbreviated to PV |
| PHS | Public Health Services Act (USA - biological products - see also FD&C) |
| 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/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 |
| PMF | Plasma Master File (Alternative name for an SMF - US term mainly) |
| POM | Prescription Only Medicine |
| PQ | Performance Qualification or Process Qualification |
| PQG | Pharmaceutical Quality Group |
| PQR | Product Quality Review (EU) |
| PV | Process Validation or sometimes used as an abbreviation for Phamacovigilance |
| PVAR | Provisional Variation Assessment Report (EU) |
| QA | Quality Assurance |
| QC | Quality Control |
| QbD | Quality by Design |
| QMS | Quality Management System |
| QP | Qualified Person (EU) |
| QWP | Quality Working Party (of the CHMP - EU) |
| RMS | Reference Member State (EU) |
| RP | Responsible Person (Distribution within the EU) |
| RO | Reverse Osmosis - a method of producing high quality water |
| SAT | Site Acceptance Test(ing) |
| SBA | Summary Basic of Approval (USA) |
| 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) |
| SNDA | Supplementary New Drug Application |
| SmPC | Summary of Product Characteristics (also SPC) EU: Medicinal Product |
| 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 |
| USP/NF | United States Pharmacopoeia/National Formulary |
| USAN | United States Approved Name |
| 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) |
| WL | Wholesale Dealers' Licence (UK) |
| WFI | Water for Injection |
| WHO | World Health Organisation |
| /R chart | Mean and Range chart (an SPC tool) |
| XMF | Excipient Master File (EU) |