Abstract
Pharmaceutical quality systems (PQS) according to ICH Q10 require the identification of processes that need to be measured. Designing and maintaining a metrics system in a way that serves its purpose well requires careful consideration of various aspects in order to meet expectations. The purpose of using key performance indicators (KPIs)/Metrics can be defined by main aspects that include: a. supporting the achievement of objectives by making them measurable, b. reaching comparability and/or standardization of performance for organizational units, c. achieving objectiveness in assessing performance. The first two aspects are closely linked to management responsibilities. Therefore, management needs to be strongly involved with the activities of setting up and maintaining a metrics system. This paper provides an overview of the points to be considered when setting up and managing a quality-related metrics system.
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