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FDA’s Call for Quality: Revamped GMP Initiative Stresses Cost Savings

This article was originally published in RPM Report

Executive Summary

FDA is kicking off phase two of its 21st Century GMP initiative using new authorities and funding under the FDA Safety & Innovation Act. To encourage investment in quality manufacturing systems, the agency is highlighting the cost savings seen by early adopters of quality systems. And if that’s not incentive enough, FDA has already shown it is quite willing to use the new enforcement authorities. Ranbaxy is a case in point.

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