Additional Changes to GMP Regulations Are Under Development

Now that the FDA has completed the first part of changes to its GMP regulations, work on more significant modifications is under way, according to an agency director.

“This is really where the quality systems changes will come into play. This is where we want to strengthen the regulations in terms of quality systems as we envision them for the 21st century,” Mary Anne Malarkey, director of the Center for Biologics Evaluation and Research’s Office of Compliance, said at the 2008 Parenteral Drug Association (PDA)-FDA Joint Regulatory Conference.

The first phase of the GMP revisions takes effect Dec. 8 and includes changes in the requirements for verifications of critical production steps and an explicit mandate to validate aseptic processes.

The FDA has been working on Phase II of the GMP revisions for quite some time, Malarkey said. She could not say when the new regulations would be released but noted they would go through the standard rule-making process—a proposed rule would be issued rather than a direct final rule—unlike the most recent GMP changes.

Stricter GMP requirements for the pharmaceutical industry are likely as large-scale recalls and compliance issues have prompted congressional investigations.

SOURCE: FDA NEWS