Module 3 Presentations

07/05/2024

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

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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Comparison Traditional vs RTR(t) Control Strategy

Background 1:  UK-xxxxxx , wet granulated tablet product , highdose (500 mg +), high drug loading (60%)  Formulation containing Avicel, Lactose, PVP, Croscarmellose Sodium and Magnesium Stearate  Compound entering Development Phase Background 2:  UK-yyyyyy , direct fill capsule , lowdose (5-10 mg), standard / low drug loading (5%)  Formulation containing Avicel, Lactose, Maize Starch, Talc  Established Compound in production

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

26