FDA first-party audit program to involve 25 firms with evident GMP compliance.
This article was originally published in The Tan Sheet
Executive Summary
FDA FIRST-PARTY AUDIT PILOT PROGRAM TO INVOLVE 25 FIRMS based on their records of compliance with Good Manufacturing Practices over the last two years, the agency states in a proposal for modified GMP inspections released April 14. "Participation in the pilot program needs to be limited to a reasonable, manageable number of participants yet...be large enough to allow fair evaluation. For these reasons, FDA believes that 25 firms should be an adequate number of participants," the agency explains. The pilot will run for two years. The proposal is posted on FDA's Web site at www.fda.gov.