« Vocabulaire industrie pharmaceutique » : différence entre les versions
Aller à la navigation
Aller à la recherche
Aucun résumé des modifications |
Aucun résumé des modifications |
||
| (Une version intermédiaire par le même utilisateur non affichée) | |||
| Ligne 11 : | Ligne 11 : | ||
|dossier maître de la substance active | |dossier maître de la substance active | ||
|<nowiki>https://www.ema.europa.eu/en/active-substance-master-file-procedure-scientific-guideline</nowiki> | |<nowiki>https://www.ema.europa.eu/en/active-substance-master-file-procedure-scientific-guideline</nowiki> | ||
|- | |||
|BEP - Biological Evaluation Plan | |||
| | |||
| | |||
|- | |||
|BER - Biological Evaluation Report | |||
| | |||
| | |||
|- | |||
|BI - Biocompatibility Information | |||
| | |||
| | |||
|- | |- | ||
|CDMO - | |CDMO - | ||
| Ligne 32 : | Ligne 44 : | ||
|DVSR - Design Verification Summary Report | |DVSR - Design Verification Summary Report | ||
|''Summary with top level results of the full design verification'' | |''Summary with top level results of the full design verification'' | ||
| | |||
|- | |||
|EDDO - Essential Drug Delivery Output | |||
| | |||
| | | | ||
|- | |- | ||
| Ligne 66 : | Ligne 82 : | ||
Société de recherche contractuelle | Société de recherche contractuelle | ||
| | |||
|- | |||
|CSRA - Cybersecurity Risk Analysis | |||
| | |||
| | | | ||
|- | |- | ||
| Ligne 131 : | Ligne 151 : | ||
| | | | ||
|<nowiki>https://www.thefdagroup.com/blog/a-basic-guide-to-iq-oq-pq-in-fda-regulated-industries</nowiki> | |<nowiki>https://www.thefdagroup.com/blog/a-basic-guide-to-iq-oq-pq-in-fda-regulated-industries</nowiki> | ||
|- | |||
|Label | |||
|Informations visibles sur le produit (étiquette, gravage, marquage laser...) | |||
| | |||
|- | |- | ||
|SME - Subject Matter Experts | |SME - Subject Matter Experts | ||
| Ligne 178 : | Ligne 201 : | ||
|- | |- | ||
|QP - Qualified Person | |QP - Qualified Person | ||
| | |||
| | |||
|- | |||
|RMF - Risk Management File | |||
| | | | ||
| | | | ||
Dernière version du 12 mars 2026 à 11:38
| 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 |
| BEP - Biological Evaluation Plan | ||
| BER - Biological Evaluation Report | ||
| BI - Biocompatibility Information | ||
| CDMO -
Contract Development Manufacturing Organisations |
Sous-traitant pour recherche/fabrication/conditionnement des médicaments | https://pharmaoffer.com/fr/blog/what-are-cmos-and-cdmos/ |
| DMR - Device Master Record | everything needed to produce and test the device | |
| DHF - Design History File | complete description of how the device was designed | |
| DHR - Device History Record | everything needed to produce, release and supply the device | |
| DVSR - Design Verification Summary Report | Summary with top level results of the full design verification | |
| EDDO - Essential Drug Delivery Output | ||
| GAMP - Good Automated Manufacturing Practice | ||
| GCP - Good Clinical Practice | ||
| GLP - Good Laboratory Practice | ||
| GMP - Good Manufacturing Practice | ||
| 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 |
|
| CSRA - Cybersecurity Risk Analysis | ||
| 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 | ||
| MAB - Monoclonal antibody | ||
| MAF - MAster File approach | ||
| MES -
Manufacturing Execution System |
||
| 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 | |
| Label | Informations visibles sur le produit (étiquette, gravage, marquage laser...) | |
| 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 | ||
| RMF - Risk Management File | ||
| SKID ? | ||
| Observation de tâche |
Entités
| Acronyme | Pays | Description |
|---|---|---|
| CDER - Center for Drug Evaluation and Research | USA | |
| Swiss Medic | CH | Institut suisse des produits thérapeutiques |
| CBER - Center for Biologics Evaluation and Research | USA | |
| FDA - Food and Drug Administration | USA |