The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf?source=govdelivery
Content:
This guidance is intended to help manufacturers of positron emission tomography (PET) drugs meet the requirements for the Agency’s current good manufacturing practice (CGMP) regulations for PET drugs (21 CFR part 212).
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