![]() ICH Q12 adds key process parameters (KPPs) these are elements of the manufacturing process that may not be linked directly to CQAs but should be monitored in the move toward a Six Sigma–capable process. ![]() ICH Q10 defines CQAs, critical process parameters (CPPs), and critical material attributes (CMAs) as key elements of product and design. ICH-DEFINED ENABLERS Knowledge management and quality risk management This requires information exchange into the decision hierarchy, along the value chain, and across the value network. When combined with the new enablers digital maturity and data integrity by design, they form a holistic control strategy for the complete product life cycle. New elements made possible by digitalization are shown in blue. ICH Q10 elements and enablers are shown in grey. This model combines the submission-based and manufacturing control strategies to create a PQS and control strategy that covers the complete product life cycle. The four “elements” of the operating model and the “enablers” data integrity by design and digital maturity are shown in Figure 2. The quality management process in Pharma 4.0™ is based on ICH Q10: “Pharmaceutical Quality Systems” (PQS).1 In 2017, the Pharma 4.0™ SIG published an award-winning article in Pharmaceutical Engineering showing how ICH Q10 can be enriched with “elements and enablers” to benefit from new technologies. “Pharmaceutical Quality System: Q10.” 4 June 2008.
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