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Comparability Protocols for Post-approval Changes

Recently FDA published a comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.

This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) with implementing a chemistry, manufacturing, and controls (CMC) post-approval change through the use of a comparability protocol (CP).

A CP is a comprehensive, prospectively written plan for assessing the effect of a proposed post approval CMC change(s) on the identity, strength, quality, purity, and potency of a drug product, including a biological product (i.e., product),as these factors may relate to the safety or effectiveness of the product (i.e., product quality).

Submission of a CP in an original application or in a prior approval supplement (PAS) to an approved application allows FDA to review a description of one or more proposed CMC post approval changes, any supporting information and analysis, including a risk assessment, a plan to implement the change(s), and, if appropriate, a proposed reduced reporting category for the change(s).

Approval of the original application or a subsequent PAS containing the CP provides an agreed-upon plan to implement the specified change(s), and in many cases, a justification to report the change(s) in a reduced reporting category, contingent upon your analysis of the data from the implementation of the change(s).

In many cases, submission and approval of a CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a product into distribution or facilitating a proactive approach to reinforcing the supply of the product sooner than if a CP were not used.

The drivers for such changes include business needs, expanding markets, process improvements, potential for drug shortage, and accelerated manufacturing development that sometimes occurs with drugs eligible for expedited programs.

This guidance 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 life cycle of a product
  • An effective pharmaceutical quality system

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