IPEC e-newsletter - Excipients Insight February 2018 - 28-02-18

 

Inside this issue

     

Argentina publishes GMPs for Pharmacopeial Products

Towards the end of 2017, Argentina’s health authority ANMAT has published a new document – Good Manufacturing Practices of Pharmacopeial Products – which included sections on quality systems, good quality control practices, self-inspection and auditing and raw materials, amongst others.

An English translation is available – you can contact the IPEC Europe Secretariat for a copy – and we encourage IPEC Federation members, EXCiPACT and other interested parties to take a look and examine whether the guidance is in line with IPEC, EXCiPACT and ANSI 363 excipient GMP guidelines. IPEC has also reached out to Argentinian trade association SAFYBI for feedback on the new document.

 

 

 

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