Module 3 Presentations

07/05/2024

RTR(t) Control Strategy • The need for routine performance of the following tests may be Eliminated providing sufficient data is available from PU, Scale-up and Clinical Manufacture • Impurities (Degradation Products)  No degradation during PQ, Scale-up and routine manufacture • Micro  GMP Control of Inputs, Understanding of Water Activity (Aw), ‘Validation’ during ICH  Can consider skip lot testing (e.g. every 20th batch) • If process, product and controls are fully understood then lots of batch data is not a prerequisite • Product will still meet acceptance criteria if tested

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

29

RTR Approach Dependent on Manufacturing want/needs, compatibility of product and formulation

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

30