FDA Proposes GMP Revisions

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:

• 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.

Proposed ruleDirect final rule

Additional analysis of the proposed changes is available from

Immel Resources