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The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs).
The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs). The changes have been issued as a direct final rule and as proposed rules with comments due by February 19, 2008. Should no significant comments be received, the rule will be finalized on April 17, 2008.
According to the announcement in the Federal Register on December 4 (Volume 72, Number 232), the amendments being proposed are intended to “clarify and modernize the cGMP regulations, as well as harmonize the regulations with international GMP requirements and other FDA regulations.” The changes are the first set of proposed changes to parts 210 and 211.
Some of the proposed changes include:
Details of the proposed changes can be found on the FDA’s web site.
Proposed ruleDirect final rule
Additional analysis of the proposed changes is available from