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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]

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...

24

Feb

FDA Revises Nitrosamine Guidance to Extend Recommended Timeframe for Nitrosamine Risk Assessments to March 31, 2021

To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude...

23

Feb

European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021

The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium...

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