Federal Register Notice: FDA is making available a draft guidance for industry entitled Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. The draft guidance describes the key elements of a robust quality systems model and shows how persons implementing such a model can achieve compliance with the CGMP regulations. The document also shows where FDA can harmonize across agency Centers and with other non-U.S. pharmaceutical quality management requirements. The draft was developed by the quality systems group formed as part of the CGMP for the 21st Century initiative. It is intended to encourage the use of modern quality management system principles by the regulated industry and foster innovation and continuous improvements in pharmaceutical manufacturing. To download this guidance, click here. To view this notice, click here.
