FDA issued a draft guidance in April with recommendations on using a Comparability Protocol (CP) when implementing a chemistry, manufacturing and controls (CMC) postapproval change. FDA defines a CP as a comprehensive plan for “assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality).” When assessing how a CMC change may affect product quality under a CP, be sure to have the following established for continuous improvement:
- An 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
For more information, read Dan Stanton’s article at in-PharmaTechnologist. Let Pearl Pathways help you with your CMC approach and regulatory submissions for both drug substance and drug product. Contact us here.