Pharma Sector Explores How To Embrace The Fourth Industrial Revolution
While many in the pharmaceutical sector pay lip service to the digital industrial revolution called 4.0, few have embraced it. But that could be about to change.
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The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.
Biogen’s “recipe-driven qualification” knowledge management program standardizes data collection and reporting in the laboratory, with efficiency gains of 66%.
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.