The Food and Drug Administration (FDA) has posted new guidance for compliance with PET CGMP inspections.
The FDA posted the Compliance Program Guidance Manual for PET CGMP Drug Inspections. FDA’s Compliance Programs provide instructions to FDA personnel for inspecting facilities, sampling and analyzing FDA-regulated products, and initiating and implementing regulatory follow-up, when appropriate. FDA personnel who will be involved in evaluation PET production facilities are being trained to use the PET Compliance Program, to know the PET CGMP regulations and guidance, and to understand the unique aspects of PET production.
FDA has indicated it will offer webinars to the PET community to explain this program and provide general information about FDA inspection practices beginning in 2012. Information about the webinars will be posted as it is received.
To view the compliance manual, visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM277416.pdf