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25

Gen

Revision of PIC/S Aide Memoires (PI 009-4; 024-3; 028-2; 038-2)

the following PIC/S guidance documents have been revised:




  • PI 009-4 Aide Memoire on Utilities

  • PI 024-3 Aide Memoires on Biotech

  • PI 028-2 Aide Memoire on Packaging

  • PI 038-2 Aide Memoire on Assessment of QRM Implementation



The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021...[PIC/S]

26

Feb

EMA updates IDMP Implementation Guide, plans further revisions

EMA has updated its identification of medicinal products (IDMP) implementation guide, providing...

26

Feb

AIFA: tep 1 della call for review sulla nitrosammine: valutazione del rischio

Il comitato per i medicinali per uso umano (CHMP) ha richiesto che tutti i titolari dell'autorizzazione...

25

Feb

Indian drugmakers look to reduce dependence on China-made APIs

Since June 2020, India and China have seen their relations sour due to skirmishes at the border. And...

24

Feb

New Zealand seeks feedback on adopting new PIC/S Guide to GMPs

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is holding a public consultation...

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