Proposed Rule Defines Good Manufacturing Practices For Combo Products

Article preview reprinted from "The Gray Sheet" - September 28, 2009

FDA released its long-awaited proposed rule on good manufacturing practices for combination products Sept. 22. Read more...

Proposed Rule Defines Good Manufacturing Practices For Combo Products
Article preview reprinted from "The Gray Sheet" - September 28, 2009 

FDA released its long-awaited proposed rule on good manufacturing practices for combination products Sept. 22.

The draft regulation, about four years in the making, is intended to help firms comply with necessary parts of device, drug and biologics manufacturing regulations. FDA estimates that about 300 combination product manufacturers will be affected.

But until companion guidance is developed, a number of nitty-gritty questions will remain unanswered, some industry reps say.

In particular, it is unclear which FDA center will oversee compliance by the maker of a particular combination product, and how FDA will integrate principles of the proposed rule into its manufacturing facility inspections, says regulatory law expert and former FDA official Jim Cohen, of the law firm Buchanan Ingersoll and Rooney.

FDA Describes Streamlined GMP Approach

Combo products include two or more categories of regulated components combined into a single entity; two or more distinct product categories that are co-packaged; or products of a different category packaged separately but only intended for use with each other, where both products are required for the intended use or effect.

Each component of a combination product retains its unique regulatory status, even after combined, according to FDA. This means that, technically, a drug is required to meet all pharmaceutical current GMP regulations and a device all aspects of the quality system regulation, even if the two elements are combined into a single product.

But some products may use a "streamlined approach," intended to avoid duplicative manufacturing processes, given the overlap between device QSRs and drug cGMPs, the draft rule states.

Under the streamlined approach, firms that make single-entity or co-packaged combo products at the same facility can adopt one operating system as the baseline, and then tack on certain additional procedures as needed, the agency explains.

Specifically, combo products that comply with drug cGMPs must also comply with the following device requirements: management responsibility; design controls; purchasing controls; corrective and preventive action; and installation and servicing, if the product involves hardware that requires installation and/or servicing.

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