Can I read WHO Guidelines for API Quality Assessment on EtoBox?

WHO Guidelines for API Quality Assessment by pv is a document available to read on EtoBox.

What is WHO Guidelines for API Quality Assessment about?

The WHO Technical Report Series No. 953 outlines a procedure for assessing the acceptability of active pharmaceutical ingredients (APIs) for use in pharmaceutical products, emphasizing the importance of quality in finished pharmaceutical products (FPPs). It details the evaluation process, including the submission of API dossiers, inspections of manufacturing sites, and collaboration with national medicines regulatory authorities (NMRAs). The report aims to ensure that APIs meet WHO-recommended quality stand

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pv

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EN