FDA发布药品合同生产安排质量协议最终指南（FDA-2013-D-0558）
Contract Manufacturing Arrangements for Drugs: Quality Agreements
FDA发布药品合同生产安排质量协议最终指南，说明合同生产各方可用质量协议界定各自生产活动以确保符合CGMP。指南由CVM、CDER和CBER发布，文件编号为FDA-2013-D-0558。FDA表示可随时对该指南提交在线或书面评论。
该最终指南说明合同生产中各方可通过质量协议界定生产活动以符合CGMP要求，并说明可随时提交评论。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2013-D-0558
- Issued by:
-
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their
manufacturing activities to ensure compliance with CGMP.
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-2013-D-0558.
来源：FDA Pharmaceutical Quality Documents · fda.gov