Home > Property & Casualty > New FDA ruling on manufacturing requirements could lead to more warnings

New FDA ruling on manufacturing requirements could lead to more warnings

gmpsThe FDA issued a final ruling last month on Current Good Manufacturing Practice (CGMP) requirements for products that combine devices, drugs and/or biologics. The ruling will go into effect July 27, 2013, and clarifies CGMP requirements for products that are a mixture of any of these products as packaged together or as a single-entity combination. While in the past, the guidelines for some combination products (such as those that are manufactured and marketed separately) were fairly straightforward, the rules for “single-entity” and co-packaged combination products had been less clear.

While it is mandatory for all pharmaceutical companies to comply with CGMP regulations, they are not meant to be prescriptive instructions, since the regulations apply to so many types of drugs and devices. Instead, the rules are meant to offer a general framework which all companies should use while setting up their quality system and manufacturing process. Manufacturers must then determine the most effective and efficient method of meeting the guidelines that are applicable to their specific product.

The new ruling is similar to the FDA’s initial proposal in 2009, and applies to both existing and new products. Amid some requests that the new regulations only apply to future products, the FDA has promised to provide guidance to developers of existing combination products who will have to adjust their manufacturing systems for products already on the market. Both “specification” develops and contract manufacturers are subject to the new rules. Component manufacturers, however, were shielded from the new rules, even if the component is incorporated into the final product.

Insurers of Product Liability focus heavily on compliance with and violations of applicable regulatory guidelines and will review the FDA website for warning letters and Form 483s when performing their underwriting analysis. Though routine CGMP inspections are performed periodically, the frequency of FDA inspections is rising. In addition to insurance underwriters, additional parties such as investors, law firms and the press are interested in warning letters and 483s. Click here to learn more about some of the rising trends related to the FDA 483.


About the Author

Amy Sinclair is a Senior Vice President and co-leader of the Life Sciences Practice in WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.

617.646.0229 Asinclair@wgains.com Connect with Amy on LinkedIn

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