News about GMP/cGMP

20.09.2021

Final draft of new USP chapter <1083> Supplier Qualification

Final draft of new USP chapter <1083> Supplier Qualification

On September 15, the U.S. Pharmacopeia USP published the final draft of the chapter <1083> Supplier Qualification.


This chapter addresses the importance and quality risk-based implementation of supplier qualification. The goal is to provide guidance to the drug manufacturer in the "approach to select, assess, approve, and monitor suppliers of materials and services." Thus, in addition to a description of the process, the chapter includes a listing of tasks that the manufacturer faces and a list of risk-related items.  

The draft chapter can be found on the USP website – which requires a one-time, free registration.  

Comments on the draft will be accepted until November 30, 2021.


Source:

U.S. Pharmacopeia: Forum (Login)


 

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