Module 3 2019

Real Time Release – Ideal Case

• Ideal case: eliminate the need for the majority of end product tests through a combination of • process understanding, models/algorithms • control of inputs • in-process tests to confirm and/or control the ‘trajectory’ of the manufacturing process • End product will meet traditional specification if tested • Aspects of traditional specification still required to monitor the stability of the product • Critical Stability Indicating Parameters

The Organisation for Professionals in Regulatory Affairs