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Home Policy & Regulation News Rx-360 summary of FDA draft guidance on use of comparability protocols for CMC post-approval changes
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22 May 2016

Rx-360 summary of FDA draft guidance on use of comparability protocols for CMC post-approval changes

Guidance is intended to establish a framework to promote continuous improvement in the manufacturing of quality products.

On 20 April 2016, FDA issued the draft guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information. The guidance provides recommendations to holders of applications for human drugs and biologics on implementing a chemistry, manufacturing, and control (CMC) post-approval change through the use of a comparability protocol (CP). It replaces the draft guidance that published in February 2003, titled Comparability Protocols: Chemistry, Manufacturing, and Controls Information.

This guidance is intended to establish a framework to promote continuous improvement in the manufacturing of quality products by encouraging applicants to employ:

  • Effective use of knowledge and understanding of the product and manufacturing process

  • A robust control strategy

  • Risk management activities over a product’s life cycle

  • An effective pharmaceutical quality system.

    • This guidance document also includes content recommendations for CP submissions, modifications to an approved CP, implementation of changes according to an approved CP, and reporting changes made in accordance with an approved CP. A number of Q&As on CPs are included in the appendix to the guidance document. This guidance applies to CPs submitted to NDA, ANDAs, BLAs, and supplements to these applications regulated by CDER and CBER, although it does not apply to animal drugs.

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