A combination product, which is a combination of a drug or biologic with a device delivery constituent part, are typically designed, developed, and maintained under a robust manufacturing process. This article is targeted for companies that have existing combination products on the market or are prepping their quality management systems to be compliant with the FDA Regulations contained in CFR Part 4.
Post-market surveillance of combination products that are managed under multiple contract suppliers can be maintained with the right systems in place provided that the Product Owner is fully aware of what is required. Subject matter experts must be in place to ensure the product is properly maintained throughout the lifetime of the product. Follow the tips given in this article to help assure compliance.