The Laboratory Control System: Fulfilling cGMP Requirements - A proactive approach is needed to ensure all elements of the laboratory system are in compliance. - BioPharm International

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The Laboratory Control System: Fulfilling cGMP Requirements
A proactive approach is needed to ensure all elements of the laboratory system are in compliance.


BioPharm International


FDA expects the industry to encourage and monitor compliance and to implement and measure sustainable compliance. The industry is also expected to cooperate with the regulatory agencies in providing the complete information requested within a reasonable time frame. Shared awareness and understanding of the cGMPs are key to the success of the pharmaceutical industry and its regulators in delivering quality products to the public.

ELIZABETH THOMAS is a senior research scientist at Wyeth Research, 401 N. Middletown Rd., Pearl River, NY 10965, tel. 845.602.4747,
ANITA GROCHULSKI, RIPAL PATEL, SAM M. GEORGE, and LING ZHANG are part of Chemical and Pharmaceutical Development at Wyeth Research.

References

1. Horan RC. FDA cGMP Inspection. FDA cGMP China Training Program. 2005; Beijing, China.

2. Vesper LJ. GMP in Practice: Regulatory expectations for the Pharmaceutical Industry. Serentec Press, Raleigh, NC 2000.

3. Avallone HL, Beatrice MG, Sze, TT. Food and Drug Administration Inspection and Licensing of Manufacturing Facilities. Bioprocess Technol. 1991;13: 315–40.

4. FDA Biotechnology Inspection Guide. http://www.fda.gov/ora/inspect_ref/igs/biotech.html

5 Pharmaceutical cGMPs for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan. http:// http://www.fda.gov/cdr/gmp/2ndProgressRept_Plan.htm


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