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Pharmaceutical cGMPs for the 21st
Century: A Risk-Based Approach
Progress Report on Effective Business Practices and Policies in Other
Organizations
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.
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Date created: February 27, 2003 |
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