GMP Detox Annex 11 and Annex 22 GMP July 2025
Автор: GMP Detox
Загружено: 2025-07-05
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How difficult it is when you have to say something about rumours and assumptions. It's time to interpret the current delay. It really is just an interpretation - and it's a shame to be forced into it.
The new Annex 11 draft should have been published three month ago - and there is no announcement by the EMA or PIC/S why it is delayed or what new expected date can be given. Also there a rumours going through the GMP society that a new Annex - Annex 22 - for AI will be created. Is this how an agency should communicate to the public? What if Google knows better than we? Is it smart to implement unplanned changes causing delays and uncertainties. What about "one in/one out" for regulations?
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