Case Study of ISO 9002 versus cGMPs of Devices and Drugs

A direct comparison between American pharmaceutical and medical device clinical good manufacturing practices (cGMPs) versus International Standards Organization (ISO) 9002 has been studied via a third party audit of an industrial contract manufacturer by a generic pharmaceutical corporation. To meet future international harmonization needs, the contract manufacturer had set a goal to obtain ISO 9002 approval. As its market for components of medical devices expanded, management soon envisioned expansion into pharmaceutical production. Medical device cGMP regulations were similar to the specifications set by ISO 9002. Pharmaceutical cGMPs were seen as a deviation from the standard operating procedures for ISO 9002.