The FDA's Office of Combination Products (OCP) has released a new final regulation on the current good manufacturing practices (CGMPs) used in the manufacture of combination products.
Combination products are a combination of two or more product classes, such as a medical device, biologic and a pharmaceutical product. They are typically regulated by analyzing their constituent parts to determine their primary mode of action, which is then analyzed by the appropriate regulatory center. Because the devices combine two or more products that on their own might be regulated, they are subject to careful scrutiny in regards to their manufacturing.
Pharmaceutical and biological products are largely governed by a set of drug quality regulations under CGMP (21 CFR 210-11 and 600-680, respectively), while medical devices are manufactured under Quality Systems Regulation (QSR) regulations (21 CFR 820) and blood- and tissue-based products are regulated under 21 CFR 1271.
If the devices are physically separate, such as those packaged together, then they will follow their own separate product-specific quality regulations. The application of those rules to single-entity products is considerably more difficult and the agency explained that it wished to put forth a rule that would make the standards unified regardless of which center took the lead on regulating the product.
The new rule specifies that good manufacturing practices for combination products can be satisfied by either demonstrating compliance with all applicable regulations on a separate basis, or by meeting either:
- the CGMP regulation and applicable sections of 21 CFR 820's; or
- the quality system regulations (QSR) and the applicable 21 CFR 211's and 221's
Posted by Bruce Lehr Jan 27th 2013.