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. 

The addition of bioburden testing as an example of  in-process testing that should be carried out (Section  211.110, Sampling and testing of in-process materials and drug products);

Including sterilization as a way to clean equipment (Sec.  211.67, Equipment cleaning and maintenance); 

The requirement to validate procedures to prevent  microbiological contamination of all aseptic processes (not just sterilization  processes), in Section 211.113, Control of  microbiological contamination; 

Elimination of the EPA water standard, to be replaced with a  requirement that all water be “safe for human consumption;”

Elimination of the reference to asbestos-containing filters  from Sec. 211.72, Filters;

The requirement that  certain procedures be carried out by one person and checked by a second person  may be satisfied by the use of an automated system, if one person verifies that  the operations are performed accurately by such equipment.

Details  of the proposed changes can be found on the FDA’s web site.

Additional analysis of the proposed changes is available from 

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The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs).