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Opportunities to Statistically Mine PAT Data for Release Testing Explored

This article was originally published in The Gold Sheet

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Pharmaceutical Industry Adopting Lifecycle Models for Process Validation

The pharmaceutical industry is incorporating the lifecycle approach to process validation – and seeing some of its benefits after initial misgivings – while an FDA official discussed the elements of a robust process validation program and consequences when these are not in place. Industry is developing separate guidance on designing process validation studies for biotechnological drugs.

FDA Guidance Exempts Legacy Products from Early Stage Process Validation; Endorses Use of PAT

FDA’s final process validation guidance clarifies that legacy products, or products that are currently on the market, will be exempt from early stage process validation. The guidance also endorses the use of process analytical technology for monitoring product quality.

Regulators Encourage Transition from Batch to Continuous Processing

As pharmaceutical manufacturers increasingly look to continuous processing technologies as a way of controlling costs and potentially increasing drug quality, regulators in the U.S. and the European Union are beginning to use more flexible, quality-by-design-like approaches in evaluating these systems.

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