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CDER MAPP describes roles and responsibilities in reviewing quality portions of BLAs

This article was originally published in The Gold Sheet

Executive Summary

FDA's Center for Drug Evaluation and Research has issued a policy guide that outlines the roles of different organizations in reviewing the quality sections of new biologics license applications and supplements. It addresses the responsibilities of the Office of Biotechnology Products (OBP) in the Office of Pharmaceutical Science (OPS) and the Division of Manufacturing Product Quality (DMPQ) in the Office of Compliance in reviewing these applications. The MAPP is meant to "provide a team approach to product quality evaluation of biologics licensing application, and defines clear roles and responsibilities." For example, the DMPQ assessment lead is responsible for microbial method qualification and the OBP assessment lead is responsible for overall process design and flow for the drug substance and the non-sterility parameters of the drug product. The MAPP took effect on Dec. 22 and the policy will be re-evaluated after one year

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