Summary

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

Author:

Monitoring and Reporting Work Group

This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA issued on January 22, 2013 (final rule).  This guidance describes certain general considerations for CGMP compliance for combination products, and also includes information regarding the purpose and content of specific CGMP requirements addressed in the final rule. Hypothetical scenarios that illustrate how to comply with certain CGMP requirements for specific types of combination products are also presented.  Cross-references are provided to existing FDA guidance and additional resources that address CGMP requirements for drugs, devices, biological products, and HCT/Ps, to further inform combination product manufacturers on how to comply with CGMP requirements.

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