FDA says GMP Compliance Going from Bad to Worse - July 30, 2007

At a recent industry meeting, David Horowitz, FDA Office of Regulatory Affairs deputy associate commissioner for compliance policy, noted industry compliance with GMPs "is bad and getting worse." He remarked that manufacturers are "studying for the test"—correcting specific deficiencies but not investing in systems that can avoid problems and correct root causes.

FDA is urging manufacturers to adopt innovative approaches for ensuring that drugs meet quality standards, as seen in its Quality Systems Approach to Pharmaceutical CGMP Regulations guidance published in September 2006.

The new Q10 standard from the International Conference on Harmonization further describes approaches for harmonizing quality systems on a global basis.

How is GMP compliance in your company?
Bad and getting worse?
OR
Good and getting better?

Find both FDA’s guidance and the Q10 document at:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

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