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Insights

21st-Century OSDs: Times, They Are a Changin'

Jul 02, 2017

Insights

21st-Century OSDs: Times, They Are a Changin'

Jul 02, 2017

FDA’s current good manufacturing practices for finished drugs were first published in 1963 (1), a year before Bob Dylan’s song captured the spirit of change that was to define the decade. GMPs would become law in 1978. At most pharmaceutical facilities, however, little had changed since the 1950s, with the same manufacturing processes and equipment, and the same test-centered approaches to quality assurance.

To read more go to http://www.pharmtech.com/21st-century-osds-times-they-are-changin

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