Continued process verification: Difference between revisions

Revision as of 02:30, 2 May 2016

Revision as of 07:24, 22 November 2017

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* An alert system to identify process malfunctions that lead to deviations from quality standards.

* A framework for gathering and analyzing data of final product quality and process consistency. Analysis should include source materials consistency and manufacturing equipment condition; and data should be collected in a format that allows for long term trend analysis as well as intra-production quality analysis.

* Continued review of quality qualification standards and process reliability. Departures from any predetermined standards should be flagged for review by trained personnel and appropriate measures undertaken to restore end-to-end quality standards.<ref>{{cite web|title=Trust but Verify (Continuously)|url=http://www2.emersonprocess.com/siteadmincenter/PM%20Articles/ART-Trust-but-Verify.pdf|publisher=Pharmaceutical Manufacturingturing|accessdate=3 November 2014}}</ref>

==Data collection and analysis==