Pharmaceutical Quality Assessment -- A Science- and Risk-based CMC Approach in the 21st Century
By Joseph X. Phillips

AAPS Workshop Co-sponsored by FDA and ISPE
5-7 October, 2005
North Bethesda, Maryland

This month, I want to highlight an AAPS workshop for which I have been on the planning committee. The workshop is co-sponsored with FDA and ISPE, and is scheduled for 5-7 October in North Bethesda, MD.

This workshop is devoted to getting industry input to enable the FDA to change its Chemistry Manufacturing Controls section of NDA submissions. In my opinion, the changes FDA envisions, if implemented, will greatly simplify submissions and cut down drastically on the number of supplements now needed for post-marketing changes. I want our membership to be aware of these new developments so that they will have the opportunity to be part of this change. Persons who have an interest area in process/product/development, manufacturing, laboratories, regulatory affairs, and mechanistic understanding of products can learn and contribute to the planned changes.

The following verbiage from the AAPS workshop flyer describes this event in further detail. I recommend that our membership seriously consider attending this workshop.

"The US Food and Drug Administration (FDA) wants to sponsor open public discussion between industry, regulatory scientists, and other interested parties on the topic of how to move from the current CMC process (lacking some necessary scientific information) to a future CMC process with more science built into the submission (pharmaceutical development section) to allow for a science and risk-based assessment. It is important for both the industry and the FDA to have a mutual understanding relating to these issues and the impact on regulatory decisions. The FDA has used workshops to resolve important issues and to develop consensus reports on several occasions in the past decade. Information exchanged in these workshops and public fora complies with the Agency's Good Guidance Practices regulations (21 CFR Sec. 10,115).

"Consistent with the cGMPs for the 21st Century Initiative, the FDA is establishing a modern, risk-based pharmaceutical quality assessment system to replace the current chemistry, manufacturing, and controls (CMC) review system. The new quality assessment system is intended to facilitate innovation and continuous improvement throughout the product lifecycle to provide regulatory flexibility for specification setting; post approval changes based on scientific knowledge and understanding of product and process by applying quality by design principles; and to expedite the review of drug applications without compromising the high quality of drugs in the United States. Plenary sessions will present scientific and technical challenges to provide the framework for discussions in the breakout sessions. Breakout sessions will serve as the forum for the FDA to seek input from the public in understanding the pros and cons of the various aspects, and in identifying alternative approaches to achieve the desired state.

For detailed information on the workshop, visit www.aapspharmaceutica.com/cmc or call +1-301-694-5243. Again, I encourage participation in this workshop which can dramatically affect the nature of future application submissions.

About the Author
Joseph X. Phillips joined ISPE in 2003 as Regulatory Affairs Advisor and was appointed to the US Food and Drug Administration (FDA) as a special government employee on the Pharmaceutical Science Advisory Committee that is involved in the agency’s new “Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century” initiative. Previously, Phillips was Vice President, Pharmaceutical Services for Quintiles Consulting following a 44-year career with the FDA. At the FDA he served as Deputy Regional Director of the Agency’s Central Region. He was heavily involved in training of FDA Investigators and in planning and managing pharmaceutical programs including the Pre-Approval Inspection program and the SUPAC (Scale-Up and Post Approval Changes) for field operations. Phillips was a principal negotiator for the US/EU Mutual Recognition Agreement and was the FDA Lead to the International Conference on Harmonization (ICH) Expert Working Group for GMP Guidance for Active Pharmaceutical Ingredients (ICH Q7A Guidance)