FDA发布Q4B附件4C(R1)最终指南，涉及非无菌产品微生物检验的接受标准
Q4B Annex 4C(R1): Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
FDA发布Q4B附件4C(R1)最终指南，涉及非无菌产品微生物检验的接受标准。该附件是Q4B专家组评估并推荐部分药典文本的系列文件之一，目的是促进其在ICH区域内被监管机构认可为可互换使用，以避免行业重复检验。文件编号FDA-2008-D-0400，由CBER与CDER发布，页面更新日期为2017年9月18日。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2008-D-0400
- 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-0400.
来源：FDA Pharmaceutical Quality Documents · fda.gov