SEPT. 3–ROCKVILLE, Md.–More than a year after it announced its risk-based initiative, the Food and Drug Administration (FDA) outlined new steps in its strategic plan to modernize the regulation of pharmaceutical manufacturing and product quality with five new guidances, one of which is the final for using electronic records and signatures.

In addition, the agency is also collaborating with academia, industry and other government organizations to promote innovative approaches to drug development and regulation, and forming the Pharmaceutical Inspectorate (PI), which will consist of 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 and other complex or high- risk pharmaceutical operations.

The FDA also announced that it is actively seeking to improve international standards for drugs through efforts at supporting global harmonization, and collaboration with its public health counterparts in other nations. In particular, several scientific workshops are planned overseas during the latter part of 2003 and early part of 2004 for the purpose of educating, discussing and identifying innovative scientific approaches to achieve several goals of the Pharmaceutical cGMPs for the 21st Century initiative.

“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 Dr. 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.”

Along with a finalized version of the guidance on CFR 21 Part 11, the FDA has also released:
–A draft guidance on a process for resolving disputes arising over scientific and technical issues related to pharmaceutical current good manufacturing practices (cGMP)
–A draft guidance on the aseptic processes used in the manufacture of sterile drugs, emphasizing current science and risk-based approaches.
–A draft guidance on preparation and use of a comparability protocol for assessing chemistry, manufacturing and control changes to protein drug products and biological products.
–A draft guidance for Process Analytical Technology (PAT);a framework for allowing regulatory processes to more readily adopt stateof-the-art technological advances in drug development, production and quality assurance.

Th agency has collaborated with a number of organizations in an effort to promote innovative approaches to drug development and regulation. These include collaborations with:
–The McDonough School of Business (Professor Jeffrey T. Macher, Ph.D.), at Georgetown University, Washington, DC, and the Olin School of Business (Professor Jackson A. Nickerson, Ph.D.), at the Washington University, St. Louis. The collaboration should help the Agency identify the factors that predict manufacturing performance to further refine our pharmaceutical manufacturing risk-based assessment.
–The National Science Foundation’s Center for Pharmaceutical Processing Research allowing FDA to expand its scientific foundation in the area of innovative pharmaceutical manufacturing technology.
–A Cooperative Research and Development Agreement (CRADA) with Pfizer, Inc., to research chemical imaging applications in pharmaceutical manufacturing and quality assurance.

Comments on the initiative and the implementation plan may be submitted to Docket number 03N-0059. However, comments on the draft guidances should be submitted to the respective dockets outlined in their Federal Register notices. More information on this major initiative is available online at http://www.fda.gov/cder/gmp/index.htm.