FDA Suggests Alternatives for Demonstrating CGMP Compliance for Combination Products

The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements.

For testing and release for distribution, manufacturers can use product samples that are not finished combination products to determine whether the drug constituent part meets final specifications, the agency said. The manufacturers should demonstrate that any differences in manufacturing for representative samples compared to the finished product do not affect the combination product’s constituent parts.

In the case of drug-eluting lead manufacturers, for example, they could perform identity tests on a “representative lead tip assembly” that contains the drug constituent part but not the full electronic and mechanical assembly as long as they show that differences in the manufacturing process do not affect the drug constituent part and the sample “is representative of the finished combination product with respect to the quality attributes being tested.”