FDA 发布 Q4B 附件 2(R1) 最终指南，涉注射剂可提取体积检验通则
Q4B Annex 2(R1): Test for Extractable Volume of Parenteral Preparations General Chapter
FDA 发布 Q4B 附件 2(R1) 最终指南，内容为注射剂可提取体积检验通则。文件编号为 FDA-2008-D-0081，由 CDER 与 CBER 发布。该附件属于 Q4B 系列，旨在促进选定药典正文在 ICH 地区互认，避免行业重复检验。
该附件属 Q4B 系列最终指南，说明选定药典正文在 ICH 地区互认以减免行业重复检验的评估安排。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2008-D-0081
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
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-0081.
来源：FDA Pharmaceutical Quality Documents · fda.gov