21 CFR Part 4 did not establish any new requirements but clarified which CGMP requirements apply when drugs, devices and biological products are combined to create combination products.
This final guidance to 21 CFR Part 4
- applies to all combination products
- provides a definition of “combination product” according to FDA
- gives an overview of 21 CFR Part 4
- describes the role of the lead center and other Agency centers (e.g. CDER, CBER, CDRH)
- addresses certain general considerations for CGMP compliance for combination products
- presents the purpose and content of specific CGMP requirements addressed in 21 CFR Part 4
- analyzes hypothetical scenarios that illustrate how to comply with certain requirements for specific types of combination products (for a prefilled syringe, drug-eluting stent and drug-coated mesh)
- refers to a “CGMP operating system” meaning the operating system within an establishment designed and implemented to address and meet the CGMP requirements for manufacturing a combination product
- clarifies how to deal with constituent parts of cross-labeled combination products
- explains the two ways to demonstrate compliance
- a streamlined approach
- a CGMP/QS approach
- addresses the documentation needed for a CGMP approach.
For more details please refer to the original guideline.
FDA: CGMP Requirements for Combination Products