Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Direct Final Rule

For Pharmaceuticals:

Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Direct Final Rule

In December 2007, The Food and Drug Administration (FDA) announced amendment to its current Good Manufacturing Practice regulations for finished pharmaceuticals.  They amended the regulations to modernize or to clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice.

At the same time, the FDA also published a companion proposed rule, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. The rule becomes effective April 17, 2008.

Q: When did the last significant revision to the CGMP regulations take place?

A: In 1996.  The revision was proposed to clarify certain manufacturing, quality control, and documentation requirements and to ensure that the regulations more accurately encompass current industry practice (61 FR 20103, May 3, 1996) (1996 proposed rule).

Q: What happened to this revision?

A: As a part of the risk-based pharmaceutical CGMPs for the 21st century initiative, FDA created a CGMP Harmonization Analysis Working Group (CGMP Working Group) to analyze related CGMP requirements in effect in the United States and internationally, including those related to quality systems. The CGMP Working Group compared parts 210 and 211 (21 CFR parts 210 and 211) to the GMPs of the European Union (EU), as well as other FDA regulations (e.g., the Quality Systems Regulation, 21 CFR part 820) to identify the differences and consider the value of supplementing or changing the current regulations. Based on the CGMP Working Group's analysis, the FDA decided to take an incremental approach to modifying parts 210 and 211
(see http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm. )

Because of this change in approach, FDA decided not to finalize the
1996 proposed rule and published a notice withdrawing it.

Q: What does the new direct final rule affect?

A: Plumbing, aseptic processing, asbestos filters and verification by a second individual.  There were also some miscellaneous minor changes in the use of certain phrases to eliminate any ambiguity in the regulation.

Q: Are comments still being accepted on this amendment?

A: This rule becomes effective April 17, 2008. You may submit written or electronic comments on or before February 19, 2008. If the FDA receives no significant adverse comments during the specified comment period, they will publish a notice in the Federal Register no later than March 18, 2008, confirming the effective date of the direct final rule.

Read more about CGMP compliance:

White Paper:

Achieving Quality Across the Global Manufacturing Network

Q&A:

FDA’s Quality Systems Approach to Pharmaceutical CGMPs

Q&A:

Pharmaceutical CGMP for 21st Century




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