Using a process-centered approach to minimize the effort of compliance |
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Authors: | Ciommer B |
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Institution: | (1) Lonza AG/Exclusive Synthesis, 3930 Visp, Switzerland e-mail: bernhard.ciommer@lonzagroup.com Tel.: +41-27-948 6930 Fax: +41-27-947 6930, CH |
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Abstract: | The complexity of different quality standards can, in principle, be covered by different approaches and strategies. In-depth
process mapping of quality control (QC) work streams was used by the analytical laboratories of Lonza AG to show up the principle
differences in being compliant to different quality systems. The results identified two main drivers for all necessary actions:
process-related activities and infrastructure-related activities. In addition, a clear indication of the economic impact of
these driving forces was gained, which led the laboratories to decide on a process-oriented approach. This approach has the
advantage of being able to reflect the different demands of different quality assurance (QA) regulations within the same QC
organizational structure. Following the process helps avoid unnecessary efforts in analytical work and represents a very economical
approach, at the same time, providing high flexibility to react to different QA or customer demands.
Received: 5 July 2002 Accepted: 12 November 2002
Acknowledgements The process-oriented approach resulted from many, very challenging discussions for which I would like to thank the staff
of my organization (Analytics & QC), especially, the QA staff and the LIMS team.
Presented at Analytica Conference, 23–26 April 2002, Munich, Germany
Correspondence to B. Ciommer |
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Keywords: | Process-oriented approach Compliance to different quality systems Process mapping QC infrastructure in a GMP environment Certification according ISO 9001:2000 |
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