Gian-Andri Erich Steiger

Last Name

Steiger

First name

Gian-Andri Erich

Email

gian-andri.steiger@unisg.ch

Phone

+41 71 224 73 17

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Quality assurance excellence in the pharmaceutical industry

(EurOMA European Operation Management Association, 2023-07)
Gian-Andri Erich Steiger
;
Fabian Klinkner
;
Thomas Friedli

Since the early 2000s the Pharma Industry entered the race to excellence first in manufacturing later integrating QC. QA remained a “black box”. We therefore systematically developed a QA excellence model. Our study followed an abductive research process using the method of systematic combining. 107 interviews from six cases were condensed in a draft model. This draft was consequently revised in four verification-interviews. The finalized model thereby includes 15 fields of QA. The results showed that QA deals especially with information management. An effective and efficient QA system needs to have a strong focus on coordination and risk-management.

Type: conference paper

URI: https://www.alexandria.unisg.ch/handle/20.500.14171/117875