FDA发布《药物与生物制品分析程序和方法验证》最终指南
Analytical Procedures and Methods Validation for Drugs and Biologics
FDA发布《药物与生物制品分析程序和方法验证》最终指南，就申请人提交分析程序和方法验证数据提供建议。该指南替代2014年2月19日发布的同名草案（79 FR 9467），并取代2000年同名草案指南和1987年《方法验证样品与分析数据提交指南》，文件编号为FDA-2015-N-0007。
该最终指南说明申请人提交分析程序与方法验证数据的建议，并明确其替代2014年同名草案及更早文件。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2015-N-0007
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and the 1987 Guidelines for Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.
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-2015-N-0007.
来源：FDA Pharmaceutical Quality Documents · fda.gov