Final Guidance on Contract Manufacturing Quality Agreements

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA has published a final guidance on quality agreements for contract manufacturing. In particular, FDA describes how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP. The draft was announced in the Federal Register in 2013. The final version clarifies the scope of the guidance and key terms, reaffirming that it is applicable to commercial manufacturing activities only. [For an in-depth review of the development of the guidance and the GMP regulatory concerns regarding contract manufacturing, see IPQ March 20, 2013, IPQ March 25, 2013 and IPQ October 30, 2013.]
[/membership]