cGMP for Combination Products are pretty detailed and comprehensive
The FDA has pretty detailed cGMPs for combination products. It seeks to clear common confusions inherent in the topic. A fresh Draft Guidance has been issued in January 2015.
Specifications on Current Good Manufacturing Practice (cGMP) for manufacturers of combination products are set out in the set of Part 4 regulations that the FDA promulgated in 2013.
What is a combination product?
The FDA has this description of a combination product as set out in 21 CFR Part 3: “a combination product is a product composed of any combination of a drug, device, or biological product. The drugs, devices, and biological products included in combination products are referred to as “constituent parts” of the combination product”.
Overcoming confusion associated with classifying products
Each of the constituent parts of the combination product is governed by its own set of regulations on what cGMPs mean for these combination products. However, there was considerable confusion among manufacturers about cGMPs for combination products that were difficult to classify, such as when some products were both drugs and medical device. To help manufacturers overcome this, the FDA promulgated Part 4.
cGMPs prescribed in Part 4
Part 4 proceeds on the general consideration that compliance with its respective cGMP requirements should be the cornerstone for manufacturing a constituent part of a combination product. This seeks to clear the confusion regarding this issue.
Highlights of cGMPs for Combination Products:
A manufacturer of combination products has to demonstrate cGMPs by being compliant with the following:
- Part 4, which offers an exception to the general rule for combination products that are co-packaged (two or more separate products that are packaged together) or single-entity (comprised of parts that are physically, chemically, or otherwise combined into a single product) combination products.
- Accordingly, a manufacturing facility can fully comply with the cGMP requirements for any one of the constituent parts while supplementing the cGMP requirements for some specified provisions for the remaining constituent parts. Such facilities have these three options:
The Draft Guidance of 2015
The FDA issued a Draft Guidance on the subject in January 2015 making a few amendments to the above. cGMPs for combination products have been slightly revised.