Risk-Based cGMPs: A Progress Report

A Flurry of Announcements Mark the Halfway Point of FDA's Overhaul of Manufacturing Practice Guidances

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It's been one year since the Food and Drug Administration (FDA) announced its aggressive two-year overhaul of current good manufacturing practices (cGMPs) based on risk analysis. And in a September 3 press conference, FDA leaders marked the midpoint of the initiative with a flurry of announcements advancing its efforts to bring scientific and engineering discipline to bear on pharmaceutical manufacturing processes "and to the regulatory process as well.

"All of the major steps announced today are part of our program to increase efficiencies while maintaining and enhancing FDA's high standards for safety in our regulation of the manufacturing of human drugs and biologics and veterinary drugs," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "This two-year effort was launched last August, and under the direction of FDA's cGMP Steering Committee, it is on track to accelerate the public health benefits from modern methods to produce more precise, effective medicines and assure their quality."

Five new guidances were issued, one final and four draft versions for comment:

A final guidance on the use of electronic records and signatures by the regulated industry that further clarifies industry concerns regarding enforcement discretion, legacy systems and time stamps. (A draft guidance had been circulating for comment since February.)

A draft guidance on a process for resolving disputes arising over scientific and technical issues related to pharmaceutical cGMPs designed to facilitate "open and prompt discussion" leading to dispute resolution.

A draft guidance on aseptic processes used in the manufacture of sterile drugs. The guidance, last updated in 1987, now emphasizes contemporary automation and isolation techniques.

A draft guidance on the preparation and use of comparability protocols for assessing the effects of manufacturing and control changes on the quality of protein drug and biological products.

A draft guidance for process analytical technology (PAT) that is intended to provide a framework for allowing pharmaceutical manufacturers to more readily adopt new measurement and control technologies that will help build quality into products, reducing reliance on post-production quality control methodologies.

Rest assured these guidances and their implications will be covered in greater detail in future issues of Pharmaceutical Manufacturing, but meanwhile visit www.fda.gov/cder/gmp/index.htm to review and comment on these documents yourself. (And let me know what you think of them, too!)

The agency also announced a series of collaborative efforts intended to further its own expertise and to promote innovative approaches to drug manufacturing and regulation. A project with the McDonough School of Business at Georgetown University, Washington, D.C., and the Olin School of Business at the Washington University, St. Louis, is working to identify the factors that predict manufacturing performance. A joint effort with the National Science Foundation's Center for Pharmaceutical Processing Research is intended to expand the FDA's scientific foundation in the area of innovative pharmaceutical manufacturing technology. And a cooperative research and development agreement (CRADA) with Pfizer, Inc., will research chemical imaging applications in pharmaceutical manufacturing and quality assurance.

Finally, FDA even appears to be taking a bit of its own medicine, internalizing the quality-systems approach it is urging on industry and deepening the expertise of its field inspectors. A series of quality systems working groups are charged with implementing an agency-wide quality systems framework. And a memorandum of understanding between the Office of Regulatory Affairs and the Center for Drug Evaluation and Research established the Pharmaceutical Inspectorate (PI), a staff within the FDA field force of highly trained individuals who will devote most of their time to conducting human drug manufacturing quality inspections on the majority of prescription drug manufacturers and other complex or high risk pharmaceutical operations. The PI is also expected to conduct pre-approval inspections and may assist in investigations that would benefit from their expertise.

A team of focused inspectors, expert in pharmaceutical manufacturing technologies and in applying quality systems principles. Now that's what I'd call progress.

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