Current Good Manufacturing Practice Requirements for Combination Products
Draft Guidance for Industry and FDA Staff
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.
Section II of this document provides the definition of a combination product, an overview of the final rule, and the role of the lead center and other agency components with respect to combination product CGMP issues.
Section III addresses certain general considerations for CGMP compliance for combination products.
Section IV presents the purpose and content of specific CGMP requirements addressed in the final rule.
Section V analyzes hypothetical scenarios intended to clarify how to comply with certain CGMP requirements addressed in the final rule.
Throughout this guidance, the agency also refers to existing guidance and additional sources of information that address CGMP requirements for drugs, devices, biological products, and HCT/Ps, as further inform combination product manufacturers on how to comply with CGMP requirements.