MANUFACTURING
Predicting Quality Risks in Pharmaceutical Production Incorporating internal and external signals
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Quality risk management plays a key role within pharmaceutical production. Being able to predict quality issues and proactively maintain regulatory compliance prevents production downtimes and disruptions of medicine supply. This article outlines a comprehensive approach how to address and predict quality risks by utilising internal and external metrics. Bernasconi Matteo, Institute of Technology Management Grothkopp Mark, Institute of Technology Management Ritz Marten, Institute of Technology Management Friedli Thomas, Director, Institute of Technology Management
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P H A RM A F O C U S A S I A
ISSUE 44 - 2021
roactive quality risk management provides numerous advantages to pharmaceutical companies, such as less rejected batches, and less drug shortages (FDA, 2021a). It helps to minimise and predict potential negative impact on patients caused by quality issues, and it encourages manufacturers to adopt suitable continuous improvement programs. The combination of quality standards and good manufacturing practices constitutes the guidance for industry ICH Q10 Pharmaceutical Quality System (PQS), which sets the basis to establish a holistic quality system and a continual improvement of product quality (ICH, 2008). Academics addressed quality risks in pharmaceutical production with a special focus on two subject areas: analysing the methods and tools for managing and reducing quality risks in the processes (Altamuro et al., 2017; Ball et al., 2017; Seiss, 2018) and identifying context factors influencing quality risk at the plant level (Gray et al., 2015a; Gray et al., 2015b; Gray et al. 2016). However, both industry and academia are lacking a comprehensive approach to measure, operationalise or quantify quality risk. Regulatory programs, such as the quality metrics initiative showed that the effectiveness of a PQS cannot be assessed based on a few single key performance indicators (KPI) (Friedli et al., 2019). Similarly, a quality risk assessment
