Rx-360 Summary of U.S. FDA GMPs for Combination Products

U.S. FDA Set to Publish Final Rule for Combination Product GMPs

The GMPs for Combination Products will be published in the Federal Register soon. The draft rule published for comment in September 2009 and the final rule is very similar to the draft rule; the background and preamble to the final rule should be read because they include FDA’s specific comments and interpretation of requirements. Guidance will be necessary to promote consistent implementation of the rule and the rule mentions this will be forthcoming.

Each component, drug and device, will need to comply with the existing regulations specific to the component. When combined in a combination product, “…each of the constituent parts remains subject to its respective cGMP requirements.”

For certain classes of combination products, companies have the choice of complying with either all of the GMP requirements for both components or taking a streamlined approach whereby the company documents compliance with either the drug GMPs or the QS regulations along with demonstrating of compliance with specified provisions of the other of the two components.

For example, if a company claimed compliance with the 21 CFR 210 and 211 (including parts 600-680 if appropriate), these would need to be supplemented by compliance with the following Quality System regulations for a combination product:

§820.20, Management Responsibility
§820.30, Design Controls
§820.50, Purchasing Controls
§820.100, Corrective and Preventive Action
§820.170, Installation
§820.200, Servicing

This rule will become effective 180 days after publication, which may prove a challenge to those firms that are incorporating segments of the 820 regulations for the first time. The agency states that 180 days should not be a problem for implementation because they are only streamlining existing rules.

To view or download the Final Rule, click here