FDA发布数据完整性及药品CGMP问答最终指南（FDA-2018-D-3984）
Data Integrity and Compliance With Drug CGMP Questions and Answers
FDA发布《数据完整性及药品CGMP问答》最终行业指南，用于说明数据完整性在药品CGMP中的作用。指南因近期检查中数据完整性缺失发现增多而制定，FDA期望所有数据可靠准确，并允许采用灵活、基于风险的策略预防和发现数据完整性问题。企业应基于工艺理解及对技术和业务模式的知识管理，实施有效的数据完整性风险管理策略。
材料交代FDA发布该最终指南的背景是近期检查中数据完整性缺失增多，并列出企业据风险实施策略的方向。
GUIDANCE DOCUMENT
Data Integrity and Compliance With Drug CGMP: Questions and Answers Guidance for Industry December 2018
Final Level 1 Guidance
- Docket Number:
- FDA-2018-D-3984
- Issued by:
-
Guidance Issuing Office
Center for Veterinary Medicine
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research, Office of Regulatory Policy
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers.’’ The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance has been developed in response to an increase in findings of data integrity lapses in recent inspections. FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and riskbased strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective
strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.
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-2018-D-3984.
来源：FDA Pharmaceutical Quality Documents · fda.gov