The FDA highlighted several accomplishments in a final report issued in September 2004. They include:
■ Development of industry guidance for quality CGMP regulation. The document called “Guidance for Industry:
Quality Systems Approach to Pharmaceutical CGMP Regulations” provided recommendations to the regulated
industry on meeting CGMP requirements through a comprehensive quality approach, which encourages continuous
improvement and risk management.
■ Implementation of risk-based management plan. A risk-based orientation is one of the driving principles of the
initiative. The different aspects of this plan include: 1) development and pilot implementation of a risk-based model
for prioritizing sites for manufacturing inspections; 2) the issuance in 2003 of the industry guidance called “Part 11,
Electronic Records, Electronic Signatures – Scope and Application” to facilitate innovation for modern manufacturing,
electronic record keeping, and regulatory submissions, and to encourage the use of risk-based approaches to managing
computer systems.
■ Science-based regulation of product quality. The agency uses science-based policies and standards as
the foundation for product quality regulation to help improve the efficiency of manufacturing and regulatory
decision making.
