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The new cGMP rule for combination products

Technological innovations and newly developed drugs have resulted in combination products with multiple modes of action. The regulatory response has been a new rule for combination products finalized and issued by the FDA in July 2013. Entitled the “cGMP Rule for Combination Products”, the basic principle of the regulation is that a product is governed under a set of regulations, which are applicable to its primary mode of action.

In this PDA interview, Katja Kotter, Director Regulatory Affairs/ Quality Compliance, Vetter offers her insight into the impact of this new regulation and the response by CDMO’s and other service providers. The importance and benefits of design control and how it can be applied are also discussed, along with an in-depth review of the “waterfall model” --a sequential process flowing from conception through initiation, analysis, and implementation all the way to maintenance. Examples of how this process can be implemented are given.

Combination Products

PDA Letter

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