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U.S. Department of Health and Human Services


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Progress Report on Effective Business Practices and Policies in Other Organizations

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach

Comments on this report or on the activities of this working group should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket Number 03N-0059.

Electronic Management Comment Form:  Docket 03N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach

As part of the initiative to ensure that the Agency uses current business practices for risk and quality management, FDA will commission a study of ‘effective’ business practices and policies which could be applicable to FDA’s business model. Such a study will assist the Agency in developing approaches that improve Agency effectiveness and efficiency, and that will positively affect on industry innovation and use of the latest advances in manufacturing science and technology to improve the overall public health.

This study is intended to help improve the practices and policies of the FDA units involved in the regulation of pharmaceuticals by reviewing effective quality and regulatory system practices from other countries, industries or organizations. Relevant regulatory functions include setting quality and product performance standards; review and inspection for conformance with standards; and broader surveillance activities. Performance dimensions to be considered include:

  • Use of quality systems approaches to manage and ensure the quality of activities. For any of the functions above, or for analogous activities, how has implementation of a quality systems approach improved efficiency of the process or quality of the work product? What have been the benefits to and challenges for the organization in implementing and operating a quality system? What have been the costs and return on investment?
  • Use of risk based approaches and standards. Has the organization formally implemented a risk-based approach to a process, a product, or to quality attributes? How is risk defined? How is the risk-based approach implemented? How successful has it been in meeting the organization’s objectives?
  • Oversight of quality management by another parties. How do regulatory agencies or purchasers, respectively, oversee and ensure the quality activities of regulated industry, or their suppliers?

The proposed study would examine other organizations to identify practices that might improve the FDA regulatory process in the area of pharmaceutical product quality. Candidate organizations include public and private, domestic and international, pharmaceutical and other industries, and regulatory and non-regulatory agencies. Presentations of these practices will be made to Agency staff to stimulate thinking and awareness of different approaches used by similar and other industries and agencies.