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Comparability Protocols for Postapproval Changes to CMC

This guidance (Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA,  ANDA, or BLA) recommends a framework to promote innovation and continuous improvement in the manufacturing of quality products by encouraging you to employ:

  • Effective use of knowledge and understanding of the product and manufacturing process
  • Risk management activities over the lifecycle of a product
  • An effective pharmaceutical quality system

This guidance applies to CPs submitted in NDAs, ANDAs, BLAs, and supplements to these applications regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

However, this guidance is not applicable to blood and blood components; biological products that also meet the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); or human cells, tissues, or cellular or tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service Act and 21 CFR part 1271.

Recommendations for the use of CPs by manufacturers of licensed blood and blood components are included in a separate FDA guidance for industry on Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (December 2014).

The scope of this guidance does not include animal drugs.

This guidance incorporates the modern #regulatory concepts stated in FDA’s guidance for industry on PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (September 2004),the Pharmaceutical Quality for the 21st Century—A Risk Based Approach, the Critical Path Initiative, and the quality-by-design principles described in the International Conference for Harmonization (ICH) guidance for industry Q8(R2) Pharmaceutical Development (November 2009) (ICH Q8(R2)).

These principles are also incorporated in the following ICH guidances: Q9 Quality Risk Management (June 2006) (ICH Q9), Q10 Pharmaceutical Quality System (April 2009) (ICH Q10), Q11 Development and Manufacture of Drug Substances (November 2012) (ICHQ11), and Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes (May 2021) (ICHQ12).

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