It is therefore important to achieve an accepted understanding of readiness and maturity, starting with additional digital enablers and elements added to the ICH Q10: The Pharmaceutical Quality System along the product lifecycle. While Pharma 4.0™ has been called a new industrial revolution, its implementation will more likely resemble an evolution in which digitalization and automation meet very complex product portfolios and life-cycles. ![]() Implementing new industry 4.0-based manufacturing concepts in Pharma 4.0™ requires alignment of expectations, interpretation, and definitions with the pharmaceutical regulations.
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