Quality assurance excellence in the pharmaceutical industry

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.