Validation 4.0 Best Practices from ISPE: A New Approach to Assessing and Ensuring Product Consistency in Pharmaceutical Manufacturing and Quality Control
The International Society for Pharmaceutical Engineering (ISPE) has published a new guide that offers an early understanding of Validation 4.0, a modern approach to validation thinking in a digital world. The guide, titled The Good Practice Guide: Validation 4.0, is available for purchase and provides practical insights when adopting Validation 4.0 in practice.
The guide is structured to provide a comprehensive overview of Validation 4.0, covering methodology considerations, foundational enablers, required capabilities, and real-life case studies. It focuses on Good Manufacturing Practice (GMP) in a digital world, aiming to help organizations manage and control manufacturing processes effectively.
One of the key features of the guide is the inclusion of a Maturity Self-Assessment Tool. This downloadable Microsoft Excel file, found in the E-Reader's Materials/Supplements section, helps organizations accurately characterize their current state of maturity and identify areas for targeted improvements. The tool is not immediately accessible; purchasers must follow the accessing instructions found in the FAQ.
The guide was authored by a team including David Margetts, CEO of Factorytalk, as part of the core team and guide leads Mark Drinan of Takeda Pharmaceuticals International AG, Phil Jarvis of Grifols, and David O’Connor of No Deviation. As the guide adheres to ISPE's Good Practice standards, it is a valuable resource for any organization seeking to implement Validation 4.0 in practice.
In conclusion, The Good Practice Guide: Validation 4.0 is an essential tool for organizations looking to navigate the digital world of validation thinking. By providing practical insights and a self-assessment tool, it offers a comprehensive approach to implementing Validation 4.0 in practice, as demonstrated by real-life case studies.
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