Combination Product Sponsors: Watch Your GMPs

Combination Product Sponsors: Watch Your GMPs
Publish Date:
April 20, 2015
Authors:
Brian Bollwage, JD, Vice President, Regulatory Affairs

The U.S. Food and Drug Administration (FDA) issued its final rule on current good manufacturing practice (CGMP) requirements for combination products on Jan. 22, 2013. This rule endeavored to clarify how combination products can achieve CGMP compliance in a broad sense. On Jan. 25, 2015, the FDA issued the draft guidance, “Current Good Manufacturing Practice Requirements for Combination Products,” intended to provide additional clarification and a number of useful hypothetical examples to illustrate the appropriate application of CGMPs. This article distills the FDA’s 46-page guidance into a more manageable paper for review.