Drugs

CMC Comparability Protocol Guidance

FDA has published a final guidance, Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA, to assist applicants and holders of approved NDAs, ANDAs, and BLAs with implementing a chemistry, manufacturing, and controls (CMC) postapproval change by using a comparability protocol (CP). The document defines a CP as “a comprehensive, prospectively written plan for assessing the effect of a proposed postapproval CMC change(s) on the identity, strength, quality, purity, and potency of a drug product, including a biological product, as these factors may relate to the safety or effectiveness of the product.”

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

The document is said to recommend a framework to promote innovation and continuous improvement in the manufacturing of quality products by encouraging companies to employ:

effective use of knowledge and understanding of the product and manufacturing process;
risk management activities over a product’s lifecycle; and
an effective pharmaceutical quality system.

The guidance does not apply to blood and blood components; biological products that also meet the definition of a medical device; or human cells, tissues, or cellular or tissue-based products.

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