Quality Metrics and CMO Agreement

May 15, 2017
Naheed Sayeed-Desta

Ajay Pazhayattil

Jana Spes

Jana Spes is Vice-President, Technical Operations, Apotex, jspes@apotex.com.

BioPharm International, BioPharm International-05-15-2017, Volume 2017 eBook, Issue 1
Pages: s16-s18

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

As Naheed Sayeed, Ajay Pazhayattil and Jena Spes of Apotex write, FDA’s guidances on quality agreements and quality metrics came at just the right time to address ongoing issues.  Both guidances should benefit the industry, but, above all, the consumer, by establishing a framework for developing a culture of quality.


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