Quality & Compliance I: Combination Product Quality Systems

| 01 December 2009

This article, the fifth in a series on the regulation of combination products in the US, considers the state of the quality system regulatory framework for combination products. This article is not a commentary on the recently published proposed rule1 or the previously published draft guidance2 on quality systems for combination products. Rather, it describes approaches based on existing regulations that may be taken now to establish a compliant quality system for the manufacture of a combination product in anticipation of the final rule.


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