Abkürzungen im GDP-Umfeld
Seminarempfehlung
Thursday, 13 June 2024 9 .00 - 17.30 h
How to Audit Logistics Service Providers
Während der von CONCEPT HEIDELBERG bzw. der ECA organisierten GDP-Seminare kam mehrfach der Wunsch auf, eine Liste der im GDP-Umfeld verwendeten Abkürzungen zusammenzustellen. Wir haben eine solche Übersicht erstellt.
Allgemeine Abkürzungen
| 3PL | Third Party Logistics |
| API | Active Pharmaceutical Ingredient |
| CAPA | Corrective and Preventive Actions |
| CC | Change Control |
| CCP | Critical Control Point |
| CFR | Code of Federal Regulations |
| CGMP | Current Good Manufacturing Practices |
| COA | Certificate of Analysis (Analysenzertifikat) |
| CSV | Computer System Validation |
| DQ | Design Qualification (Designqualifizierung) |
| DSCSA | Drug Supply Chain Security Act |
| EEA | European Economic Area (Europäischer Wirtschaftsraum) |
| EP | European Pharmacopoeia (Europäisches Arzneibuch) |
| EU | Europäische Union |
| EWR | Europäischer Wirtschaftsraum |
| FD&C Act | (U.S.) Food, Drug and Cosmetic Act |
| FEFO | First Expiry First Out |
| FIFO | First In First Out |
| FMEA | Failure Mode and Effects Analysis |
| GDP | Good Distribution Practice |
| GMP | Good Manufacturing Practices |
| GSP | Good Storage Practice |
| HACCP | Hazard Analysis and Critical Control Points |
| IQ | Installation Qualification (Installationsqualifizierung) |
| KPI | Key Performance Indicator |
| LIFO | Last In First Out |
| MAA | Marketing Authorisation Application (Antrag auf Marktzulassung) |
| MAH | Marketing Authorisation Holder (Zulassungsinhaber) |
| MIA | Manufacture and Import Authorisation (Herstellungs- und Einfuhrerlaubnis) |
| OOS | Out-of-Specification |
| OQ | Operational Qualification (Funktionsqualifizierung) |
| OTC | Over-the-Counter (rezeptfreies Arzneimittel) |
| Ph. Eur. | Europäisches Arzneibuch |
| PQ | Performance Qualification (Leistungsqualifizierung) |
| QA | Quality Agreement (Qualitätsvereinbarung) |
| QA | Quality Assurance (Qualitätssicherung) |
| QK | Qualitätskontrolle |
| QM | Qualitätsmanagement |
| QMS | Qualitätsmanagementsystem |
| QP | Qualified Person (Sachkundige Person) |
| QRMS | Quality and Risk Management System (Qualitätsrisikomanagement) |
| QSV | Qualitätssicherungsvereinbarung |
| RA | Risk Analysis (Risikoanalyse) |
| RP | Responsible Person (Verantwortliche Person) |
| SMF | Site Master File |
| SOP | Standard Operating Procedure Standardarbeitsanweisung) |
| WDA | Wholesale Distribution Authorisation (Großhandelserlaubnis) |
Behörden und Organisationen
| APIC | Active Pharmaceutical Ingredients Committee | www.apic.cefic.org |
| DIN | Deutsches Institut für Normung | www.din.de |
| ECA | European Compliance Academy | www.gmp-compliance.org/ |
| EDQM | European Directorate for the Quality of Medicines & HealthCare | www.edqm.eu/en/ |
| EMA | European Medicines Agency | www.ema.europa.eu |
| FDA | U.S. Food and Drug Administration | www.fda.gov/ |
| GDPA | European GDP Association | www.good-distribution-practice-group.org/ |
| ICH | International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use | www.ich.org/ |
| IPEC | International Pharmaceutical Excipients Council | www.ipec-europe.org |
| ISO | International Organization for Standardization | www.iso.org/ |
| ISPE | International Society for Pharmaceutical Engineering | www.ispe.org |
| MHRA | Medicines and Healthcare products Regulatory Agency | www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency |
| PDA | Parenteral Drug Association | www.pda.org/ |
| PIC/S | Pharmaceutical Inspection Co-operation Scheme | www.picscheme.org |
| USP | United States Pharmacopeia | www.usp.org |
| WHO | World Health Organization | www.who.int |
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