FDA 发布组合产品 CGMP 要求最终指南（2017 年 1 月）

GUIDANCE DOCUMENT

Current Good Manufacturing Practice Requirements for Combination Products Guidance for Industry and FDA Staff January 2017

Final

Docket Number:

FDA-2015-D-0198

Issued by:

Guidance Issuing Office

Office of Inspections and Investigations

Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

Center for Drug Evaluation and Research

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

The draft of this document was issued in January 2015.

Additional copies are available from:
Office of Combination Products
Food and Drug Administration
WO32, Hub/Mail Room #5129
10903 New Hampshire Avenue
Silver Spring, MD 20993
(Tel) 301-796-8930
(Fax) 301-847-8619
http://www.fda.gov/CombinationProducts/

For questions regarding this document, contact the office of Combination Products at 301-796-8930 or [email protected].

This guidance describes and explains the final rule on CGMP requirements for combination products (final rule as codified in 21 CFR part 4) that FDA issued on January 22, 2013. Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), there were no regulations to clarify and explain the application of these CGMP requirements to combination products. The final rule was intended to provide such clarification and specify how compliance with applicable CGMP requirements may be demonstrated.

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-D-0198.