FDA 发布 PET 药品无菌制备验证用培养基模拟灌装指南定稿，编号 FDA-2011-D-0691
Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography
FDA 发布面向 PET 药品生产商的培养基模拟灌装指南定稿，文件编号 FDA-2011-D-0691，由 CDER 发布。该指南旨在帮助 PET 药品生产商满足 21 CFR part 212 中的 CGMP 要求。指南推荐的培养基模拟灌装程序仅适用于按 21 CFR part 212 以无菌工艺生产的无菌 PET 药品，公众可依据 21 CFR 10.115(g)(5) 随时提交意见。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2011-D-0691
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
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.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0691.
来源：FDA Pharmaceutical Quality Documents · fda.gov