FDA Publishes New Guidance on PET Drug GMPs
The US Food and Drug Administration (FDA) is releasing a final guidance on positron emission tomography (PET) products to help manufacturers of the drugs meet the agency's requirements for good manufacturing practices.
FDA's guidance, Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs, deals with sterile manufacturing practices for PET products.
"Most PET drugs are designed for parenteral administration and are produced by aseptic processing," explained FDA in a Federal Register notice.
"The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial byproducts, such as bacterial endotoxins," added the Register posting. "The media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution to test whether the aseptic procedures are adequate to prevent contamination during actual drug production."
FDA's final guidance is the second PET-related guidance document released in two months. A draft guidance released in February, Guidance: FDA Oversight of PET Drug Products Questions and Answers, has a comment period ending 29 May 2012.
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Regulatory Focus - FDA Releases New Draft Guidance on PET Drug Products