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Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say

 
• By Joanne S. Eglovitch

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.

Portable Raman Spectrometer - Image

Pharmaceutical industry officials recently explored how a performance-based approach to defining the established conditions for manufacturing processes outlined in the International Council on Harmonization's draft Q12 guideline could open the door for more use of process analytical technologies.

The performance-based option could provide a more efficient way to manage post-approval changes by reducing the number of changes that...

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