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ICH Q10 Supporting Advancing Pharmaceutical Quality and Pharma 4.0 Digital Maturity|
How can Q10 support advancing pharmaceutical quality and the digital maturity? The APQ guides are developed to support an improved and more efficient Pharmaceutical Quality System ready for being digitalised. The Pharma 4.0 operating model guides and supports the digitalisation of a matured PQS and its digitalised manufacturing execution processes including batch control and release along the product lifecycle. The batch execution and control activities are all defined by the control strategy. To support the implementation of real time control and release as an element of the digital transformation, The Process Analytical Technology (PAT) & Lifecycle Control Strategy (LCS) Community of Practise (COP) has developed a control strategy maturity model that helps identifying required capabilities for implementing advanced control strategies including PAT or Performance-based controls as proposed in ICH Q12.
This presentation will introduce the Process Performance and Product Quality Monitoring System APQ guide and the PAT & LCS COP control strategy maturity model and illustrates how these when combined supports the implementation of advanced process control that enables real time control and release as a Pharma 4.0 Digital Maturity element.