Enhanced Quality Metrics - Overcoming the divide of Quality and Excellence
Type
applied research project
Start Date
01 October 2014
End Date
03 March 2016
Status
ongoing
Keywords
OPEX
Quality
Description
Designing a quality metrics analysis for the pharmaceutical industry using the St.Gallem Operational Excellence Data base
Leader contributor(s)
Funder(s)
Topic(s)
Overcoming the divide of quality and excellence
Method(s)
Mixed Methods
Range
HSG Internal
Range (De)
HSG Intern
Division(s)
Eprints ID
241591

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Publication

What are the 10 Hot Topics in Pharmaceutical Operational Excellence for 2015?: Status Quo Analysis from an Operations Management Perspective

2015-07-09 , Friedli, Thomas , Mänder, Christian , Ponce, Nicolas

The following article presents an overview on the 10 hot topics in regards to pharmaceutical manufacturing. This analysis is based on research work of St.Gallen Operational Excellence (OPEX) team from the University of St.Gallen. Perhaps not surprisingly one of the main issues is the increasing integration of OPEX and quality, which requires novel management approaches. This and further topics are described in order to be primed for upcoming changes.

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Publication

Painting a Better Picture of Quality

2015-10-12 , Mänder, Christian , Friedli, Thomas

The FDA's approach to quality oversight has evolved in recent years, particularly with the establishment of the new Office of Pharmaceutical Quality (OPQ). OPQ exists within the Center for Drug Evaluations and Research (CDER) as a single unit dedicated to product quality with a simple mission: "to assure that quality medicines are available for the American public". In 2013, the FDA announced in the publication of the FDA Administration Safety and Innovation Act (FDASIA) that they intended to examine the use of selected quality metrics (the exact metrics will be decided upon and collected during an FDA quality metrics program) to support their risk-based inspection program. And more recently, the FDA published its draft guidance for industry related to the quality metrics request (1).

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