WASHINGTON, DC (October 4, 2004) – Following the second anniversary of the launch of its Pharmaceutical Manufacturing Initiative, the Food & Drug Administration (FDA) last week issued a final report that highlights specific steps the agency has taken and will take to develop and implement quality systems management and a risk-based product quality regulatory system.

The report describes the accomplishments and plans for the future resulting from FDA’s completed assessment of the current good manufacturing practice (CGMP) regulations, current practices, and the new tools in manufacturing science that it says will enable a progression to controls based on quality systems and risk management.

“Americans must have confidence in the quality of their medications even as we face more sophisticated technology and manufacturing processes,” Tommy Thompson, secretary of Health & Human Services, said. “This final report provides clear guidance for both FDA and manufacturers to implement a risk-based quality assessment system that will ensure that the drug supply in the United States is of consistently high quality.”

Dr. Lester M. Crawford, FDA acting commissioner said, “The accomplishments and next steps announced demonstrate FDA’s commitment and continued progress toward modernizing the regulation of manufacturing and product quality for both human and veterinary drugs as well as biological products. FDA’s CGMP steering committee has completed its two-year assessment of existing CGMP programs, and the agency has begun to implement a new scientific and risk-based approach to pharmaceutical manufacturing and product quality.”

FDA’s initiative has focused on its current regulation of pharmaceutical quality, encompassing veterinary and human drugs, and select human biological drug products such as vaccines. The report issued last week addresses FDA’s findings, which put the agency on a path to develop a product quality regulatory system for the future. The report describes specific steps the agency is taking to achieve this system.

Some of these include:

·The formation of a Council on Pharmaceutical Quality that will be charged with policy development and continuing change management, including the ongoing implementation of certain quality management systems within FDA relating to pharmaceutical quality regulation;

·A first step in establishing a new risk-based pharmaceutical quality assessment system is to replace the current chemistry, manufacturing and controls review system, in the Office of New Drug Chemistry within the Center for Drug Evaluation & Research;

·The issuance of a draft guidance on the role of quality systems in the pharmaceutical current good manufacturing practice regulations to ensure agency regulatory practices encourage similar progress in the pharmaceutical industry as well as enabling manufacturers to tailor their quality system to fit their specific manufacturing environment;

·More systematic risk-based approaches to inspectional oversight of pharmaceutical manufacturing, beginning with pilot implementation of a risk-based model for prioritizing domestic manufacturing sites for many human drug CGMP inspections;

·The issuance of a final guidance on aseptic processing used in the manufacturing of sterile drugs, encouraging the adoption of modern science and technology and risk-based approaches;

·The issuance of a final guidance on Process Analytical Technology – a framework for allowing regulatory processes to more readily adopt state-of-the-art technological advances in drug development, production and quality;

·The publishing of a draft guidance on good manufacturing practice for combination products, (i.e., products combining components from two or more of these regulatory categories: Drug, device, or biological product);

·     Continued active collaboration with the International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products, leading to the implementation of an internationally harmonized plan for a pharmaceutical quality system based on an integrated approach to risk management and science; and

·FDA’s decision to seek membership in the Pharmaceutical Inspection Cooperation Scheme – a cooperative agreement among national health regulatory authorities whose purpose includes leading international development, implementation, and maintenance of harmonized CGMP standards and Quality Systems of worldwide pharmaceutical inspectorates.

In addition, the FDA cited the following accomplishments as underscoring the agency’s commitment to realizing the specific goals of the initiative:

·A proposed rule amending Part 11, Electronic Records, Electronic Signatures – Scope & Application is expected to be published for public comment in 2005;

·A draft guidance on the use of computerized systems in clinical trials, once finalized, will replace the guidance of the same name issued in April 1999;

·The implementation of a technical dispute resolution process for CGMP disputes;

·The upcoming finalization of guidance on preparation and use of a comparability protocol for assessing chemistry, manufacturing and control changes to chemical entities, protein drug products and biological products;

·Improved integration of the preapproval and CGMP inspection programs through training, certification, and Center detail opportunities for the 26 candidates, who have just completed their first level of training, chosen for the Pharmaceutical Inspectorate; and

·The implementation of a revised Charter by the Team Biologics Operations Group that adopts a quality systems management framework, improves processes for communication and coordination between headquarters and the district offices, and further integrates product specialists into the program.

The FDA said that making improvements in the way it regulates pharmaceutical manufacturing and product quality is necessary to require the use of the best scientific data available, to develop quality standards, and to use efficient systems and practices that will provide clear and consistent decisions and communications for the regulated industry and the American public.

More information on this major initiative, as well as the final report, is available online at http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm.