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Quality assurance excellence in the pharmaceutical industry

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.

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Learn from your Metrics - Using Operational Data to Improve Operations in Pharmaceutical Manufacturing and QC Labs

2022 , Bernasconi, Matteo , Steiger, Gian-Andri Erich , Ritz, Marten , Friedli, Thomas

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Benchmarking Pharmaceutical Quality Control Labs - Holistic assessment of operational excellence in pharmaceutical companies

2022 , Gian-Andri Erich Steiger , Lorenzo Pirrone , Marten Ritz , Thomas Friedli

Through the years pharmaceutical companies have managed to apply Operational Excellence (OPEX) and Lean-thinking to their operations. Nevertheless, the majority still lacks behind when incorporating an end-to-end perspective. A first step to holistically assess the performance of pharmaceutical companies necessarily incorporates quality control (QC) in addition to manufacturing. Therefore, the St.Gallen QC Lab Benchmarking helps to position pharmaceutical QC labs from a broad range of pharmaceutical companies against each other.