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Improve efficiency and sustainability of manufacturing processes and help meet product safety by leveraging the digital transformation described by the Pharma 4.0 Plug and Produce initiative.
Life science production processes need to respect several Good Manufacturing Practices (GMP). Meeting GMP requirements relies upon the Quality by Design (QbD) approach. Identifying the Critical Material Attributes and the Critical Process Parameters (CPP) to define the Critical Quality Attributes is pivotal to applying the QbD principles.
Discover key updates to ISPE GAMP 5 Second Edition >
Discover key updates to Annex 1 of EudraLex GMP guidelines >
A Eurotherm Digital Engineered Solution (DES) leverages the available technology to harness a digital manufacturing approach. The DES conceives and documents a path to analyze the CPPs’ attributes, helping to optimize operation equipment and processes and meet the Pharma 4.0 expectations.
A DES supports the digital transformation of pharmaceutical laboratories, R&D and manufacturing plants with the potential to improve efficiency, safety, and sustainability.
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Eurotherm DES’s are focused on key applications with embedded QbD, to help reduce project execution costs, risks and time to market while complying with regulations.
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