FDA Announces New Progress Toward “21st Century” Regulation of Pharmaceutical Manufacturing
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FDA Announces New Progress Toward “21st Century” Regulation of Pharmaceutical Manufacturing
On the first anniversary of the launch of its initiative, the Food and Drug Administration (FDA) today outlined new steps in its strategic initiative to modernize the regulation of pharmaceutical manufacturing and product quality. This initiative aims at ensuring that regulatory review, compliance and inspection policies are based on state-of-the-art pharmaceutical science, and do not impede rapid adoption of new technological advances by the pharmaceutical industry. It also promises to enhance safety and quality in drug manufacturing while increasing efficiencies. Its achievements reflect valuable advice provided to FDA through many public workshops and meetings, and written comments from experts and interested parties in academics, industry, and other groups.
“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.”
First, the agency issued five new guidances designed to enhance the consistency and coordination of its drug quality regulatory programs. These include:
- A guidance for FDA regulated industry on the use of electronic records and signatures
- A draft guidance on a process for resolving disputes arising over scientific and technical issues related to pharmaceutical current good manufacturing practices (cGMP)
- A draft guidance on the aseptic processes used in the manufacture of sterile drugs, emphasizing current science and risk-based approaches.
- A draft guidance on preparation and use of a comparability protocol for assessing chemistry, manufacturing and control changes to protein drug products and biological products.
- A draft guidance for Process Analytical Technology (PAT) —a framework for allowing regulatory processes to more readily adopt state–of-the-art technological advances in drug development, production and quality assurance.
Second, the agency has collaborated with academia, industry and other government organizations to promote innovative approaches to drug development and regulation. These include:
- Collaboration 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.
- Collaboration with 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.
Third, FDA has taken steps to streamline and improve its internal processes. A Memorandum of Understanding (MOU) between The Office of Regulatory Affairs and the Center for Drug Evaluation and Research was signed on August 22, 2003, setting up the Pharmaceutical Inspectorate (PI). The PI 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 drug manufacturers and other complex or high risk pharmaceutical operations. The PI will also conduct pre-approval inspections and may conduct or assist in investigations that would benefit from their expertise.
Fourth, FDA 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.
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.
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