GMP Detox: Annex 11 and 22 Draft September 2025
Автор: GMP Detox
Загружено: 2025-09-09
Просмотров: 136
Описание:
Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22 (published on 7 July 2025) - Comments on the draft documents can be submitted until 7 October 2025.
This GMP Detox Session contains background information about the IWG governance approach and procedures and the planned content of Annex 11 and Annex 22 (only with little examples).
We encourage commenting (officially at EMA) and love to hear your thoughts in the comments of this YT clip:
changed chapter structure
new audit trail functions (changed definition from 1992)
no PIC/S PI 011 update planned
guideline style changed to guidance language
Annex also applicable to API (GMP Part II)
all manual entries should be audit trailed
extensive security aspects for GMP inspections
introduction of "software qualification"
and so on
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