Vocabulaire industrie pharmaceutique

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/
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
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
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
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

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

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