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EU23CEDEC1/SES203 - Advanced Data-Driven Process Performance and Product Quality Monitoring System (PPPQMS) for Real Time Quality Decisions

‐ Dec 11, 2023 3:30pm

Pharmaceutical Product Quality is the outcome of enhanced process understanding combined with decisions made based on process and product data. In this session I will discuss how the pharmaceutical quality can be enhanced by having access to the right data at the right point in time, making it possible to make real time quality decisions. Being able to make such decisions requires an improved Process Performance and Product Quality Monitoring System (PPPQMS) by acknowledging the digital opportunities that we have. In order to express an enhanced process understanding in a Holistic Control Strategy and to be able to make real-time quality decisions, we must have access to real-time process and product data; have systems connected across the manufacturing supply network; and have defined supportive analytical and continual improvement elements. The ISPE APQ PPPQMS guide has been developed to support the industry in establishing a PPPQMS system with its different elements for Quality 4.0. At this session I will provide practical examples of the elements of this system.


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