Module 3 2019

For successful RTR(t)

RTR development efforts should start early in the development life cycle if desire RTR at time of filing ● Extensive process understanding that determines quality critical attributes (RFT & QbD) ● PAT may be applicable but is not a requirement for RTR ● Product quality can be assured in different ways for different products and for the same product – e.g. alternative tests / controls (control of inputs, real-time measurements, end product testing) Legacy products can also make use of RTR ● Manufacturing experience at commercial scale with confidence in process controls ● Secure understanding of batch to batch variability should enable RTR

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