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).2 (21 Code of Federal Regulations (CFR) from 4). Prior to issuance of the final rule, ALTHOUGH CGMP règlements Were in place to suit les requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT / Ps), There Were No règlements to Clarify and explain the implementation of These CGMP requirements to combination products. The final rule Did not suit les Any new requirements; It was Intended to Clarify qui CGMP requirements apply When drugs, devices, and biological products are combined to create combination products, and to set forth a transparent and streamlined Regulatory framework for firms to use When Demonstrating compliance with CGMP requirements applicable.
Section II of this paper Provides the definition of "combination product," an overview of the final rule, and Describes the role of the center and lead components --other Agency4 with respect to product combination CGMP issues. Section III addresses certain general considerations for CGMP compliance for combination products. Section IV presents the purpose and content of specific Finally, Section V analyzes hypothetical scenarios that illustrate how to comply with certain requirements. Throughout this guidance, the Agency also refers to existing guidance and additional resources that address specific requirements for drugs, devices, biological products, and HCT / Ps.