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Operational Excellence in the Pharmaceutical Industry
Type
benchmarking project
Start Date
01 January 2003
End Date
22 December 2024
Status
ongoing
Keywords
OPEX Benchmarking
Description
Since 2004, the Institute of Technology Management at the University of St.Gallen (ITEM-HSG), Switzerland, and the Transfer Center for Technology Management at the University of St Gallen (TECTEM), Switzerland, are conducting an international research project in the Pharmaceutical Industry in the field of Operational Excellence. This continuous benchmarking project deals with the implementation of Lean Thinking and the principles of Operational Excellence in the Pharmaceutical Industry. The results provide participating companies the opportunity to position their production sites against a broad range of pharmaceutical production sites and show possibilities to improve productivity, quality and the reduction of lead time. Since 2008 companies can enter our continuous benchmarking process at any time. Our OPEX database includes more than 270 pharmaceutical manufacturing sites (API, Formulation & Packaging, Biotech) of more than 120 different companies ranging from small and medium-sized companies to Big Pharma.
Leader contributor(s)
Member contributor(s)
Funder(s)
Topic(s)
Operational Excellence
Method(s)
Benchmarking
Range
HSG Internal
Range (De)
HSG Intern
Division(s)
Eprints ID
238006
2 results
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1 - 2 of 2
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PublicationOperational Excellence in the Indian Pharma Industry : Real - time Online Delphi Study - Results( 2013-11-01)http://www.ipapharma.org/news/Delphi%20Study_Operational%20Excellence%20in%20the%20Indian%20Pharma%20Industry_Report.pdfType: presentation
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PublicationThe Evolution of Operational ExcellenceThe history of operational excellence (OPEX) in the pharmaceutical industry is short; the first serious OPEX initiatives were only launched about 10 years ago. Before that, the pharmaceutical industry was reluctant to put OPEX and continuous improvement on its agenda, in part because of the regulatory environment but also because it was not suffering from the same cost pressures facing other industries, such as the automotive and electronics sectors, which were forced to adopt OPEX earlier. The discussion about a more scientific approach to pharmaceutical manufacturing only really began at a US FDA scientific advisory board meeting towards the end of 2001. The agency was facing an increasing number of post-approval manufacturing amendments at the time, making it tough to fulfill their review and inspection obligations. It became apparent that the industry did not truly understand its own manufacturing processes and that there were gaps in the science needed to gain useful knowledge. Current good manufacturing practices (cGMP) were being driven more by experience than sound science, which raised concerns, as did the overly risk-averse nature of industry and regulators.Type: newspaper articleJournal: The Medicine MakerIssue: 0114