Description
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). Most PET drugs are designed for parenteral administration and are produced by aseptic processing. The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial byproducts, such as bacterial endotoxins. A 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. Media fill procedures recommended in this guidance apply only to sterile PET drugs manufactured by aseptic processes under 21 CFR part 212.
Scope & Applicability
Product Classes
2Positron Emission Tomography drugs requiring aseptic manufacturing.
Submissions that may qualify for a waiver from eCTD requirements
Stakeholders
2Person whose actions may cause a product to be deemed adulterated
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Duration for which media fill containers are held, specified as no less than 14 days.
Identified Hazards
Hazards
1Environmental factors affecting biological products
Related Warning Letters (2)
- 2025-12-16
CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
3D Imaging Drug Design and Development LLC
- 2022-05-10
CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
Brigham and Women’s Hospital Inc.
See Also (8)
- Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry (Status: Final)
- PET Drug Products - Current Good Manufacturing Practice (CGMP) (Status: Final)
- PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)
- Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (Status: Final)
- FDA Oversight of PET Drug Products -- Questions and Answers (Status: Final)
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (Status: Final)
- Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry (Status: Final)