Clarity on Manufacturing Rules for Combination Products May Come Soon

FDA's Office of Combination Products is expected to publish two proposed rules by the end of the year, its director said at the Regulatory Affairs Professionals Society annual conference this week. Thinh Nguyen said the topics are good manufacturing practices for combination products and adverse event reporting for combination products.The former has been anticipated by industry for a long time. Device manufacturing is governed by the Quality System Regulation, while pharmaceutical manufacturing is governed by the Good Manufacturing Practices Regulation.

September 19, 2008

1 Min Read
Clarity on Manufacturing Rules for Combination Products May Come Soon

The office put out a draft guidance in 2004 about how these should be integrated for combination products, but has not issued any further official word.Nguyen implied that the proposed rule on GMPs won't be too different from the 2004 draft guidance. "When it comes out, you won't be too surprised," he said. "In the meantime, work with us and have patience."The draft guidance states that before the constitutent parts are combined, they should follow the manufacturing rules that already govern them. Once they are combined, they should follow one set of rules, and incorporate select provisions from the other set of rules. Manufacturers should have a plan in place that determines which of those provisions are and are not needed. But the guidance is unclear on which set should be primarily followed for which products, when exactly "combination" occurs, and what to do about products that are used and/or marketed together but not manufactured together.The office is also about ready to publish a guidance on imaging devices for use with radiopharmaceuticals, Nguyen said. Also forthcoming are two guidances on autoinjectors, he added. One will cover the regulatory pathway for them, and the other will cover testing and other technical information.

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