Digitalization is the key to advanced operations quality processes. The ISPE Pharma 4.0TM Operating Model provides the Elements and Enablers, which are adding to the ICH Q10 Pharmaceutical Quality Systems Elements and Enablers by digitalizing the best practice approaches of an Advanced Pharmaceutical Quality System. Adding to the technical Industry 4.0 basic principles, enhancing Industry 4.0 to Pharma 4.0. The model is based on the combination of Industry 4.0 principles and is tailored for the pharmaceutical industry as a Pharma 4.0 Operating Model. The presentation will point out how the maturity of the advanced quality processes will be enabled by applying digitalization. Digitalization is not only enabling quality monitoring, it is enabling quality control based on holistic real time data. The cost of quality and quality control is tremendous in the pharmaceutical industry. The ICH Q10 Pharmaceutical Quality System Guideline provides the Enablers and Elements, which will be developed
to an Advanced Pharmaceutical Quality System based on ISPE Advancing Pharmaceutical Quality (APQ) Good Practice Guides (GPG). The ISPE
APQ Program can be enhanced by applying digitalization based on the ISPE Pharma 4.0TM Operating Model which enhances the concept of the ICH Control Strategy to a Holistic Control Strategy (HCS), which arches end-to-end - from the dossier to starting materials (API or e.g patients cells) via scale up, manufacturing processing, formulation, fill & finish/packaging via distribution up to the patient. The HCS approach will enable an end to end strategy to quality processes along the Development, Product and Manufacturing Supply Chains. Data management & analytics will enable not only quality monitoring, this will enable proactive, preventive and predictive quality control based on accurate data for decision making coming directly from the process or with advanced approaches out of digital twins for prediction.
The presentation is based on the ISPE Pharma 4.0TM Operating Model and the ISPE APQ program, combining digital transformation and quality operations excellence, delivering compliance in pharmaceutical operations for free.
Christian Woelbeling is Executive Industry Advisor & Senior Strategic Account Manager Software at Körber Business Area Pharma, based in Lüneburg, Germany.
Christian holds a Master Degree in Mechanical Engineering. For over 32 years working in Life Sciences Manufacturing IT, Christian has great experience in all GMP-related processes. He is actively involved in the ISPE, e.g. as Founder & Leader of the Community of Practice / CoP “Pharma 4.0”, ISPE GAMP Member at large of the European Steering Committee, ISPE “Advancing Pharmaceutical Quality” APQ Core Team Member, “PAT & Lifecycle Control Strategy” CoP Steering Member, and ISPE Affiliate DACH Board Member. Chrisian was named a “Pharma Industry Leader” by the ISPE Pharmaceutical Engineering Magazine in 2020. He is one of the lead authors of the ISPE Pharma 4.0 Baseline Guide.
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