FDA Releases cGMP Draft Guidance For Combination Products
The U.S. Food and Drug Administration recently issued draft guidance outlining current good manufacturing practice (cGMP) requirements for combination products. The draft guidance intends to clarify cGMP requirements for combination products and provides hypothetical scenarios illustrating compliance considerations for certain types of combination products.
The new document gives an overview of the agency's final rule for Current Good Manufacturing Practice Requirements for Combination Products, which was released in 2013 and codified in 21 CFR Part 4. The draft guidance also references other guidances and resources related to cGMP requirements for drugs; biologics; devices; and human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Attorneys from the law firm Hogan Lovells noted in an article on Lexology that the draft guidance also offers FDA advice on cGMP compliance regarding certain types of combination products, specifically drug-eluting stents, prefilled syringes, and drug-coated mesh (Section V). These hypothetical scenarios emphasize how cGMP requirements can be streamlined for such products.
In the draft guidance, the FDA defines a combination product as a product that comprises any combination of drugs, device, or biologics, referred to as its constituent parts (Section II). These may be further classified into single-entity, co-packaged, and cross-labeled combination products. The draft guidance reiterates that the preamble to the final rule states that "the cGMP requirements for constituent parts of cross-labeled combination products that are manufactured separately and not co-packaged are the same as those that would apply if these constituent parts were not part of a combination product."
For single-entity and co-packaged combination products, the guidance offers two ways for manufacturers to demonstrate compliance:
- Demonstrate compliance with all cGMP regulations applicable to each of the constituent parts included in the combination product.
- Iimplement a streamlined approach, demonstrating compliance with either the drug cGMPs (21 CFR part 211) or the quality system (QS) regulation (21 CFR part 820) rather than demonstrating full compliance with both, when the combination product contains both a drug and a device, under certain conditions.
As such, the new FDA guidance gives medical device manufacturers latitude to establish their own cGMP process within reasonable boundaries, according to the Regulatory Affairs Professionals Society (RAPS). Manufacturers will still be required to demonstrate compliance with quality processes and to justify quality measures they choose to adopt.
The FDA will accept electronic comments on the draft cGMP guidance within 60 days of its publication in the Federal Register, or until late March this year.