Vocabulaire industrie pharmaceutique
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| FSP - functional service partner | Présence sur site d'une autre entreprise | |
| API - Active Pharmaceutical Ingredient | ||
| ASMF - Active substance Master File (DMF en américain Drug Master File) | dossier maître de la substance active | https://www.ema.europa.eu/en/active-substance-master-file-procedure-scientific-guideline |
| CDMO -
Contract Development Manufacturing Organisations |
Sous-traitant pour recherche/fabrication/conditionnement des médicaments | https://pharmaoffer.com/fr/blog/what-are-cmos-and-cdmos/ |
| CMC - Chemistry, Manufacturing, and Controls | ||
| CMO - Contract Manufacturing Operation | Organisation (entreprise/societé) de fabrication sous contrat | |
| CPV - Continued process verification | https://en.wikipedia.org/wiki/Continued_process_verification | |
| CRO - Contract research organization | Recherche / organisation de recherche clinique
Société de recherche contractuelle |
|
| CTD - Commun Technical Document | référence aux matières, aux installations et équipements, au personnel, et leurs environnements, qu’aux méthodes et au système de maîtrise de la qualité dans la fabrication, la transformation, l’emballage et le stockage de l’API. | |
| CVQ -
Commissioning, Qualification, and Validation |
https://biotech.com/2023/10/26/the-complete-cqv-where-to-start/ | |
| DSP - downstream process | ||
| E&L -Extractables & Leachables | FDA 21 CFR 211.94, the Product Quality Research Institute (PQRI), USP, EMA, EP 3.1, EP 3.2, ISO 10993, and ICH Q6A,
| |
| EMA - European Medicines Agency | ||
| Excipient | Matière non-active | |
| MA - Marketing Autorisation | AMM - Autorisation Mise sur le Marché | |
| MaH : Marketing Authorisation Holder | ||
| MES -
Manufacturing Execution System |
||
| MAB - Monoclonal antibody | ||
| Papa | ||
| PPQ - Process Performance Qualification | https://en.wikipedia.org/wiki/Process_performance_qualification_protocol | |
| PQ - Performance Qualification | https://www.thefdagroup.com/blog/a-basic-guide-to-iq-oq-pq-in-fda-regulated-industries | |
| SME - Subject Matter Experts | ||
| SOP - Standard Operation Process | Procédures Opérationnelles Standardisées – POS | |
| Uls - utility lab service | Propre à thermo? | |
| USP - upstream process | Rekombineneten element | |
| IQ - Installation Qualification | ||
| HVAC - Heating, Ventilation Air Conditioning | ||
| DS – Drug Substance | ||
| BDS - Bulk Drug Substance | ||
| QA - Quality Assurance | ||
| QC - Quality Control | ||
| CNC - Controlled-not-classified | ||
| QP - Qualified Person | ||
| SKID ? | ||
| Observation de tâche |