Drugs

ICH Principles MAPP Issued

The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures (MAPP) on applying three International Council on Harmonization (ICH) principles to chemistry, manufacturing, and controls review of drug applications. The MAPP says the ICH Q8(R2) document published 11/20/09 provides information on how to present knowledge gained when applying scientific approaches and quality risk management for developing and manufacturing a product. An annex in that document clarifies key concepts in the original guidance and describes the principles of quality by design. The ICH Q9 quality risk management guidance, published 6/1/06 provides information on systematic approaches to quality risk management, while the 4/7/09 ICH Q10 pharmaceutical quality system guidance establishes a new ICH tripartite model for an effective quality management system for the pharmaceutical industry.

The MAPP says that the number of NDAs, INDs, ANDAs, and BLAs and their supplements containing quality by design approaches has increased. Because of that increase, it says, the Center recognizes the need for reviewers to consistently implement the ICH guidances in their reviews.

The stated policy is that Office of Pharmaceutical Quality reviewers will consider ICH Q8(R2), Q9, and Q10 recommendations when reviewing applications that may or may not include quality by design approaches. Reviewers should ensure that applications contain at least the minimum information on pharmaceutical development described by ICH Q8(R2) as “at a minimum, those aspects of drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined and control strategies justified.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome