FDA 发布 Q4B 附录 4A(R1) 终版指南，涉及非无菌产品微生物检查的微生物计数试验总论
Q4B Annex 4A(R1): Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter
FDA 发布 Q4B 附录 4A(R1) 终版指南，针对非无菌产品微生物检查中的微生物计数试验，供 ICH 区域监管机构将该药典文本作为可互换文本互认。文件编号为 FDA-2008-D-0396，由 CBER 与 CDER 发布，页面更新于 2017 年 9 月 18 日。文件称 Q4B 附录的实施意在避免行业重复检测，并说明可随时按 21 CFR 10.115(g)(5) 提交意见。
文件说明 Q4B 专家工作组对选定药典文本的评估与建议机制，可用于了解该附录在 ICH 区域的互认定位与意见提交渠道。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2008-D-0396
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
[updated 9/18/2017]
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
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-2008-D-0396.
来源：FDA Pharmaceutical Quality Documents · fda.gov