Im Überblick
GMP-Glossar
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Amtliche und allgemein gebräuchliche Abkürzungen im GMP-Umfeld
| Abkürzung | Erklärung |
| Ziffern | |
| 483 | Form FDA 483 (Mängelauflistung) |
| A | |
| AANDA | Abbreviated Antibiotic New Drug Application |
| ABPI | Association of British Pharmaceutical Industries |
| AHU | Air Handling Unit |
| AIM | Aide Memoire (der ZLG) |
| AISI | American Iron and Steel Institute |
| AL | Aktions Limit |
| AMBO | Arzneimittelbetriebsordnung (Österreich) |
| AMBV | Arzneimittel-Bewilligungsverordnung (Schweiz) |
| AMG | Arzneimittelgesetz (Deutschland) |
| AMG-EV | AMG-Einreichungsverordnung (Deutschland) |
| AMGrHdlBetrV | Arzneimittelgrosshandelsbetriebsverordnung (Deutschland) |
| AMWHV | Arzneimittel- und Wirkstoffherstellungsverordnung (Deutschland) |
| AMRadV | Verordnung über radioaktive oder mit ionisierenden Strahlen behandelte Arzneimittel (Deutschland) |
| AMZV | Arzneimittel-Zulassungsverordnung (Schweiz) |
| ANADA | Abbreviated New Animal Drug Application |
| ANDA | Abbreviated New Drug Application |
| ANSI | American National Standards Institute (heute: ASA) |
| API | Active Pharmaceutical Ingredient |
| APIC | Active Pharmaceutical Ingredient Council |
| ApBetrO | Verordnung über den Betrieb von Apotheken (Deutschland) |
| ApoG | Gesetz über das Apothekenwesen (Deutschland) |
| APIC | Active Pharmaceutical Ingredients Committee |
| APR | Annual Product Review |
| AR | Annual Report |
| ASA | American Standards Association |
| ASME | American Society for Mechanical Engineers |
| ASME-BPE | American Society for Mechanical Engineers – Bioprocessing Equipment |
| ASMF | Active Substance Master File |
| ASTM | American Society for Testing and Materials (inzwischen internationale Standardisierungsgesellschaft) |
| ATCC | American Type Culture Collection |
| B | |
| BACPAC | Bulk Actives Postapproval Changes (Regularium der US-FDA) |
| BAH | Bundesverband der Arzneimittel-Hersteller e.V. |
| BDSG | Bundesdatenschutzgesetz |
| BfArM | Bundesinstitut für Arzneimittel und Medizinprodukte |
| BFAV | Bundesforschungsanstalt für die Viruskrankheiten der Tiere |
| BFS | Blow-Fill-Seal (Technologie) |
| BGBl | Bundesgesetzblatt (Deutschland) |
| BLA | Biologic License Application |
| BMG | Bundesministerium für Gesundheit |
| BMS | Building Management (Computer-) System |
| BP | British Pharmacopoeia |
| BPI | Bundesverband der Pharmazeutischen Industrie e. V. |
| BPC | Bulk Pharmaceutical Chemicals |
| BPE | Bulk Pharmaceutical Excipients |
| BPI | Bundesverband der Pharmazeutischen Industrie e. V. |
| BPR | Batch Production Record |
| BR | Batch Record |
| BRR | Batch Record Review |
| BS | British Standard |
| BSA | Bovine Serum Albumine |
| BSE | Bovine Spongiform Encephalopathy (Rinderwahnsinn) |
| BtM | Betäubungsmittel |
| BtMG | Betäubungsmittelgesetz |
| BVL | Bundesamt für Verbraucherschutz und Lebensmittelsicherheit |
| BZ | „Beipackzettel“ (Gebrauchsinformation) |
| C | |
| CA | Competent Authority |
| CANDA | Computer Assisted New Drug Application |
| CAPA | Corrective and Preventive Action |
| CBE | Change being effected |
| CBER | Center for Biologics Evaluation and Research |
| CCS | Contamination Control Strategy |
| CDER | Center for Drug Evaluation and Research |
| CE | CE-Kennzeichung (Communauté Européenne) |
| CEFIC | European Chemical Industry Council |
| CEN | Comité Européen de Normalisation (Europäisches Komitee für Normung) |
| CENELEC | Europäisches Komitee für die elektrotechnische Normung |
| CEP (CoS) | Certificate of Suitability to the Monographs of the European Pharmacopoeia |
| CFR | Code of Federal Regulations |
| CFU | Colony Forming Unit |
| cGMP | Current Good Manufacturing Practice |
| CHMP | Committee for Medicinal Products for Human Use (früher CPMP) |
| CIM | Computer Integrated Manufacturing |
| CIP | Cleaning in place |
| CMC | Chemistry, Manufacturing and Controls (Teil des Zulassungsdossiers) |
| CMS | Change Management System |
| CMS | Concerned Member State |
| CoA | Certificate of Analysis |
| COP | Cleaning off place |
| COS | Certificate of Suitability (Synonym für CEP) |
| COTS | Commercial Off the Shelf |
| CP | Centralized Procedure |
| Cp | =Prozessfähigkeitsindex bzw. potentielle Prozessfähigkeit Statistische Kennzahl zur Bewertung des Herstellprozesses; beschreibt das Verhältnis der Streuung des Prozesses zur Spezifikationsbreite ohne die Lage der Werte in Betracht zu ziehen und zeigt somit die mögliche Prozessfähigkeit bei mittiger Lage der Werte an |
| Cpk | = kleinster Prozessfähigkeitsindex; Statistische Kennzahl zur Bewertung eines Herstellungsprozesses; gibt an wie sicher die produzierten Einheiten die festgelegten Spezifikationsgrenzen eines Prüfaspektes (z.B. Wirkstoffgehalt) einhalten. |
| CPMP | Committee for Proprietary Medicinal Products |
| CPP | Critical Process Parameter |
| CPV | Continued Process Verification (US FDA) oder Continuous Process Verfication (EU) |
| CQA | Critical Quality Attribute |
| CRO | Contract (Clinical) Research Organisation |
| CRS | Chemical Reference Standard (des EDQM) |
| CSV | Computer System Validation |
| CTA | Clinical Trial Application |
| CTD | Common Technical Document |
| CTX | Clinical Trial Excemption |
| CV | Computer Validation |
| CVMP | Committee for Veterinary Medicinal Products |
| D | |
| DAB | Deutsches Arzneibuch |
| DAMA | Deutsche Arzneimittel- und Medizinprodukteagentur |
| DAMOS | Drug Application Methodology with Optical Storage |
| DAR | Deutscher Akkreditierungsrat |
| DC | Dünnschichtchromatographie |
| DCS | Distribution Control System |
| DEHS | Di-Ethyl-Hexyl-Sebacat |
| DGHM | Deutsche Gesellschaft für Hygiene und Mikrobiologie (jetzt: VAH) |
| DHSS | Department of Health and Human Services (UK) |
| DIMDI | Deutsches Institut für Medizinische Dokumentation und Information |
| DIN | Deutsches Institut für Normung |
| DIP | Drying in Place |
| DKD | Deutscher Kalibrierdienst |
| DMF | Drug Master File |
| DOH | Department of Health (UK) |
| DOL | Dampf-Ozon-Luftverfahren |
| DOP | Di-Octyl-Phthalate |
| DP | Drug Product |
| DQ | Design Qualification |
| DS | Design Specifications |
| E | |
| EBR | Electronic Batch Record |
| eCTD | Electronical CTD |
| EC | European Communities |
| EC DG Enterprise |
Generaldirektorat der Europäischen Kommission |
| EDMA | European Diagnostics Manufacturee Association |
| E-DMF | European Drug Master File |
| EDQM | European Directorate for the Quality of Medicines & HealthCare |
| EEA | European Economical Area |
| EFG | Expertenfachgruppe der Überwachungsbehörden der Länder bei der ZLG |
| EFTA | European Free Trade Association |
| EFPIA | European Federation of Pharmaceutical Industries´ Association |
| EG | Europäische Gemeinschaften |
| EGA | European Generic Medicines Association |
| EHEDG | European Hygienic Equipment Design Group |
| EIR | Establishment Inspection Report |
| ELA | Establishment Licence Application |
| EM | Environmental Monotoring |
| EMA | European Medicines Agency |
| EMEA | European Agency for the Evaluation of Medical Products (veraltet) |
| EMR | Elektro-Mess-Regel (Technik) |
| EN | Europäische Norm |
| EP | European Pharmacopoeia (Ph. Eur.) |
| EPA | Environmental Protection Agency |
| ERP | Enterprise Resource Planning |
| ETO | Ethylenoxid |
| EU | European Union, Europäische Union |
| EuAB | Europäisches Arzneibuch (siehe Ph.Eur.) |
| Eucomed | European Confederation of Medical Suppliers |
| EuGH | Gerichtshof der Europäischen Gemeinschaften |
| EWR | Europäischer Wirtschaftsraum |
| F | |
| FAT | Factory Acceptance Test |
| FDA | Food and Drug Administration |
| FDAMA | Food and Drug Administration Modernization Act |
| FD&C Act | Federal Food, Drug, and Cosmetic Act |
| FDIS | Final Draft International Standard |
| FEFO | First expiry, First out (Lagerhaltung) |
| FFS | Form-Fill-Seal (Technology) |
| FFU | Filter Fan Unit |
| FIFO | First in, First out (Lagerhaltung) |
| FIP | Fédération Internationale Pharmaceutique |
| FIR | Failure Investigation Report |
| FIRA | Federal Insecticide, Fungicide and Rotenticide Act |
| FMEA | Failure Mode and Effects Analysis, Fehlermöglichkeiten- und Einflussanalyse |
| FOI | Freedom of Information (act) |
| FR | Federal Register |
| FS | Feasibility Study |
| F(D)S | Functional (Desgin) Specifications |
| FTA | Fault Tree Analysis |
| FTIR | (Fast) Fourier Transformation Infrared Spectroscopy |
| G | |
| GAMP | Good Automated Manufacturing Practice (Guide der ISPE) |
| GAP | Goos Analytical Practice |
| GC | Gaschromatographie |
| GCLP | Goos Control Laboratory Practice |
| GCP | Good Clinical Practice |
| GCP-V | GCP-Verordnung (Deutschland) |
| GCVP | Good Computer Validation Practice |
| GDP | Good Distribution Practice |
| GEP | Good Engineering Practice |
| GHTF | Global Harmonization Task Force |
| GLP | Good Laboratory Practice |
| GMP | Good Manufacturing Practices |
| GSP | Good Storage Practice |
| GWP | Good Warehousing Practice |
| H | |
| HAB | Homöopathisches Arzneibuch |
| HACCP | Hazard Analysis and Critical Control Points |
| HAT | Hardware Acceptance Test |
| HAZOP | Hazard Operability Analysis |
| HDS | Hardware Design Specifications |
| HEPA | High Efficiency-Particulate Airfilter |
| HHS | Department of Health and Human Services |
| HIMA | Health Industries Manufacturers Association |
| HKL | Heizung Klima Lüftung |
| HMG | Heilmittelgesetz (Schweiz) |
| HPLC | High Performance Liquid Chromatography |
| HVAC | Heating, Ventilating and Air Conditioning |
| HWG | Heilmittelwerbegesetz (Deutschland) |
| I | |
| IB | Investigators Brochure |
| ICH | International Conference on Harmonisation |
| IEEE | Institute of Electrical and Electronic Engineers, Inc. |
| IEST | Institute of Environmental Sciences and Testing |
| IFPMA | International Federation of Pharmaceutical Manufacturers Associations |
| IMPD | Investigational Medicinal Product Dossier |
| INADA | Investigational New Animal Drug Application |
| INN | International Non-proprietary Names |
| IND | Investigational New Drug Application |
| IPAC-RS | International Pharmaceutical Aerosol Consortium on Regulation and Science |
| IPC | In-Process-Control |
| IPEC | International Pharmaceutical Excipients Council |
| IQ | Installation Qualification |
| IR | Immediate Release oder Infrarot |
| IRB | Investigation Review Board |
| ISO | International Organization for Standardization |
| ISPE | International Society for Pharmaceutical Engineering |
| IVDD | In-vitro-diagnostics directive |
| J | |
| JP | Japanische Pharmacopoe |
| JPMA | Japan Pharmaceutical Manufacturers Association |
| K | |
| KBE | Kolonien bildende Einheiten |
| KPI | Key Performance Indicater |
| L | |
| LAF | Laminar Air Flow |
| LAL | Limulus Amoebocyte Lysate (Test) |
| LD 50 | Lethal Dose 50 |
| LdH | Leitung der Herstellung |
| LdQ | Leitung der Qualitätskontrolle |
| LEFO | Last Expiry, First Out |
| LF | Laminar Flow |
| LIFO | Last in, First Out |
| LIMS | Labor-Informations-Management-System |
| LOD | Limit of Detection, auch für Loss on Drying |
| LOQ | Limit of Quantification |
| LVP | Large Volume Parenterals |
| LW | Luftwechsel |
| LYO | Lyophilisator |
| M | |
| MA | Marketing Authorisation |
| MAA | Marketing Authorisation Application |
| MAH | Marketing Authorisation Holder |
| MBR | Master Batch Record |
| MCA | Medicines Control Agency (UK) |
| MCB | Master Cell Bank |
| MDD | Medical Device Directive |
| MDR | Manufacturing Deviation Report |
| MES | Manufacturing Execution System |
| MHLW | Ministery of Health, Labour and Welfare (Japan) |
| MHRA | Medicines and Healthcare products Regulatory Agency (Großbritannien) |
| MHW | Ministry of Health and Welfare (Japan) |
| MIL | Military Standardization Document |
| MKT | Mean Kinetic Temperature |
| MMP | Microbial Monitoring Programme |
| MOU | Memorandum of Understanding |
| MPG | Medizinproduktegesetz |
| MR | Modified Release |
| MRA | Mutual Recognition Agreement |
| MRF | Mutual Recognition Fatligation (Procedure) |
| MRP | Mutual Recognition Procedure |
| MS | Member State (der EG) |
| MSR | Messen – Steuern – Regeln |
| MVC | Minimum Valid Concentration |
| MVD | Maximum Valid Dilution |
| N | |
| NADA | New Animal Drug Application |
| NAMUR | Normenausschuß Mess- und Regeltechnik |
| NAT | Nukleinsäure Amplifikationstechniken |
| NBE | New Biological Entity |
| NCE | New Chemical Entity |
| NDA | New Drug Application |
| NDE | New Drug Entity |
| NF | National Formulary |
| NIH | National Institute of Health (USA) |
| NIHS | National Institut of Health Sciences |
| NIR | Near Infrared Spectroscopy |
| NIST | National Institute of Standards and Technology (USA) |
| NME | New Molecular Entities |
| NMR | Nuclear Magnetic Resonance |
| NUI | Non urgent information (zu Nebenwirkungen oder Qualitätsmängeln) |
| NUIS | Non urgent information system (der EG und der EFTA zu Nebenwirkungen und Qualitätsmägeln) |
| O | |
| OECD | Organization for Economic Cooperation and Development |
| OMCL | Official Medicines Control Laboratory |
| OOE | “Out of Expectation” |
| OOL | “Out of Limit” |
| OOS | „Out of Specification“ |
| OOT | „Out of Trend“ |
| OOT | “Out of Tolerance” |
| OPV | Ongoing Process Verification |
| OQ | Operational Qualification |
| ORA | Office of Regulatory Affairs (Inspektorat der US FDA) |
| ORO | Office of Regional Operations (US FDAs) |
| OTC | Over the Counter (medications) |
| P | |
| PA | Prior Approval |
| PAI | Pre-Approval Inspection |
| PAR | Proven Acceptable Ranges |
| PAS | Prior Approval Supplement |
| PBR | Production Batch Record |
| PCR | Polymerase Chain Reaction |
| PCS | Process Control System |
| PDA | Parenteral Drug Association |
| PEI | Paul-Ehrlich-Institut |
| PES | Peressigsäure |
| PET | Positronen Emissions-Tomographie |
| PhD | Doctor of Philosophy |
| Ph. Eur. | European Pharmacopoeia |
| PharmBetrV | Pharmabetriebsverordnung |
| pharmInd | „Die pharmazeutische Industrie“ (Fachzeitschrift) |
| PhRMA | Pharmaceutical Research and Manufacturers of America Foundation |
| PI | Pharmaceutical Inspectorate (US FDA) |
| P&I (D) | Piping and Instrumentation (Diagram) |
| PIC | Pharmaceutical Inspection Convention |
| PIC/S | Pharmaceutical Inspection Cooparation Scheme |
| PID | Proportional – Integral – Differential (-Regler bzw. Reglung) |
| PKI | Public Key Infrastructure |
| PL | Product Licence |
| PLA | Product Licence Application |
| PLC | Programmable Logic Controller |
| PLS | Prozess-Leit-System |
| PMA | Pharmaceutical Manufacturers Association |
| PMAC | Pharmaceutical Manufacturers Association of Canada |
| PMF | Plant Master File |
| PMS | Post Marketing Surveillance |
| ppb | Parts per billion |
| ppm | Parts per million |
| PPQ | Process Performance Qualification |
| PPS | Produktions-Planungs-System |
| PPTA | Plasma Protein Theraputics Association |
| PQ | Performance Qualification |
| PQR | Product Quality Review |
| PQRI | Product Quality Research Institute |
| PSF | Product Specification File |
| PTB | Physikalisch Technische Bundesanstalt |
| PV | Process Validation |
| PVC | Polyvinylchlorid |
| PVDC | Polyvinylidenchlorid |
| PVDF | Polyvinylidenfluorid |
| PV | Prüfvorschrift |
| PW | Purified Water |
| Q | |
| Q7A | ICH-Dokument Q7A zu Wirkstoff-GMPs (entspricht Teil II des EG-GMP-Leitfadens) |
| QA | Quality Assurance |
| QAU | Quality Assurance Unit |
| QC | Quality Control |
| QCU | Quality Control Unit |
| QHD | Qualified Hygienic Design |
| qft | Cubic feet |
| QM | Qualitätsmanagement |
| QMS | Qualitätsmanagement System |
| QP | Qualified Person, Sachkundige Person |
| QS | Qualitätssicherung |
| QSH | Qualitätssicherungshandbuch |
| QSS | Qualitätssicherungssystem |
| QSIT | Quality Systems Inspection Technique |
| R | |
| Ra | Rauhigkeit |
| RABS | Restricted Access Barrier System |
| RAS | Rapid Alert System |
| RCS | Reuter Centrifugal Sampler |
| R&D | Research & Development |
| RH | Relativ Humidity |
| RHI | Regionales Heilmittelinspektorat (Schweiz) |
| RI | Rohrleitung und Instrumentierung (Schema) |
| RKI | Robert-Koch-Institut |
| RLT | Raumlufttechnik |
| RMS | Reference Member State |
| RO | Reverse Osmosis |
| RODAC | Replicate Organism Detection and Counting |
| RP | Regierungspräsidium |
| rpm | revolutions per minute |
| RR | Reinraum |
| RRKL | Reinraumklasse |
| RS | Reference Standard |
| RTP | Rapid Transfer Port |
| RPZ | Risiko-Prioritäts-Zahl (siehe auch FMEA) |
| S | |
| SAT | Site Acceptance Test |
| SAL | Sterility Assurance Level |
| SCADA | Supervisory Control and Data Acquisition |
| SCS | Swiss Calibration Service |
| SDS | Software Design Specification |
| SIP | Sterilisation in Place |
| SLA | Service Level Agreement |
| SMF | Site Master File |
| SOP | Standard Operating Procedure |
| SPC | Statistical Process-Control |
| SPC | Summary of Product Characteristics |
| SPS | Speicherprogrammierbare Steuerung |
| SSR | Scientific Steering Committee der EG zur TSE-Sicherheit |
| SUPAC | Scale-up and Postapproval Changes |
| SVP | Small Volume Parenterals |
| Swissmedic | Das Schweizerische Heilmittelinstitut |
| T | |
| TÄHÄV | Verordnung über tierärztliche Hausapotheken (Deutschland) |
| TAV | Turbulenzarme Verdrängungsströmung |
| TGA | Technische Gebäude Ausrüstung |
| TLC | Thin Layer Chromatography |
| TMS | Turbulente Mischströmung |
| TOC | Total Organic Carbon |
| TQM | Total Quality Management |
| TSCA | Toxic Substances Control Act |
| TSE | Transmissible Spongiform Encephalopathy |
| U | |
| UAW | Unerwünschte Arzneimittelwirkung |
| UF/DF | Ultrafiltration/Diafiltration |
| ULPA | Ultra Low Penetration Air (- Filter) |
| URS | User Requirement Specification |
| USDA | United States Department of Agriculture |
| USP | United States Pharmacopoeia |
| UV | Ultraviolett (Licht) |
| UV/VIS | Spektroskopie im UV- und sichtbaren Bereich |
| V | |
| VAH | Verbund für angewandte Hygiene e.V. (früher DGHM) |
| VAP | Verband aktiver Pharmaunternehmen |
| VAW | Verfahrensanweisung |
| VDI | Verein Deutscher Ingenieure |
| VDMA | Verband Deutscher Maschinen- und Anlagenbauer |
| VFA | Verband der forschenden Arzneimittelhersteller e.V. |
| VHP | Vaporised Hydrogen Peroxide |
| VMP | Validation Master Plan |
| VPN | Virtuell Private Network |
| W | |
| WCB | Working Cell Bank |
| WFI | Water for Injection bzw. Wasser für Injektionszwecke |
| WG | Water Gauge (Höhe Wassersäule) |
| WHO | World Health Organization |
| WL | Warning Limit |
| WIP | Washing in Place |
| WSG | Wirbelschichtgranulator |
| WST | Wirbelschichttrockner |
| Z | |
| ZLG | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten |
| ZLS | Zentralstelle der Länder für Sicherheitstechnik |
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