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GMP Detox QP Certification vs Batch Release
Автор: GMP Detox
Загружено: 2024-04-08
Просмотров: 127
Описание:
EU GMP Chapter 2 - The role of the Qualified Person - QP (PIC/S: Authorized Person - AP / Switzerland Responsible Person - FvP, see I-SMI.TI.17e of swissmedic)
What is a batch record review, batch certification and a batch release?
EU GMP EudraLex Volume 4 - Annex 16
QP cockpit and release hub / data warehouse
Roles and Responsibilities
Marketing Authorisation (MA)
Quality decision making process by QP: Certification
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