FDA发布《工艺验证：通用原则与实践》最终指南（FDA-2008-D-0559）
Process Validation: General Principles and Practices
FDA发布行业指南《工艺验证：通用原则与实践》最终版，文件编号FDA-2008-D-0559，日期为2011年1月。该指南列出FDA认为适用于人用和兽用药品及生物制品（包括原料药）生产的工艺验证通用原则与方法。文件说明可就任何指南随时提交意见，书面意见须注明该文件编号并寄至Dockets Management。
这是FDA定稿的工艺验证指南，列出其认为适用于人用和兽用药品及生物制品生产的通用原则与方法。
GUIDANCE DOCUMENT
Process Validation: General Principles and Practices Guidance for Industry January 2011
Final
- Docket Number:
- FDA-2008-D-0559
- Issued by:
-
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
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-0559.
来源：FDA Pharmaceutical Quality Documents · fda.gov