FDA Guidance for Industry: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs

Title:
FDA Guidance for Industry: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs

https://www.gmp-compliance.org/files/guidemgr/UCM273766.pdf

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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