FDA Issues Final Rule Clarifying Certain cGMP Regulations

The FDA has issued a final rule revising and clarifying its current manufacturing practice (cGMP) requirements for aseptic processing, water standards and the verification of production steps.

The changes, which the agency says will not have a substantially adverse impact on the industry, were issued in part to harmonize cGMP standards with other pharmaceutical regulators, such as the European Medicines Agency.

In conjunction with the final rule, the FDA withdrew its May 1996 proposed rule originally issued to clarify certain manufacturing, quality control and documentation requirements and update the validation of processes and methods.

Since the release of the withdrawn proposal, the FDA created the cGMP Harmonization Analysis working group in 2002 as part of its Pharmaceutical cGMPs for the 21st Century Initiative. The group was charged with formally analyzing manufacturing regulations.

The revisions “clarify and reflect long-standing agency interpretation of these regulations and industry practices,” the FDA says.

Comments are due 75 days after the rule was published in the Federal Register Dec. 4. The regulation is effective 135 days after publication. More details can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/07n-0280-nfr0001.pdf.