The FDA releases a Proposed Rule which will Define the Good Manufacturing Practices For Combo Products

On Sept. 22, FDA released its long-awaited proposed rule on good manufacturing practices for combination products. The draft regulation, is intended to help firms that are involved with combo products comply with necessary parts of device, drug and biologics manufacturing regulations.

FDA estimates that about 300 combination product manufacturers will be affected.

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.

If the firm adopts device QSRs as its baseline, it must comply with the following drug regulations:
testing and approval or rejection of components, drug product containers and closures; calculation of yield; tamper-evidence packaging for over-the counter drug products; expiration dating; testing and release for distribution; stability testing; special testing requirements; and reserve samples regs.

The added requirements should be incorporated in the firm’s operating system where “most appropriate,” and should be included in the company’s written procedures, FDA says. When combo product parts are manufactured at separate facilities, the streamlined approach does not apply: each part is subject only to device QSRs or drug cGMPs. If the parts are then packaged together at a third facility, the streamlined approach can be used during that portion of the production
process only.

You should review the guidance document and get in your comments. That is the only want to assure you have your opinion reviewed. You can find the document at http://edocket.access.gpo.gov/2009/E9-22850.htm

For more information on this new guidance document please contact mdi at info@mdiconsultants.com and ref: Combo GMP