Spring Intro 2023

03/03/2023

Real Time Release (RTR)

• Is RTR testing proposed? • Demonstrate enhanced product and process understanding? • Appropriate controls of the critical process parameters (CPP) and critical materials attributes in place to justify RTR?

 Specifications are legally binding standards  When tested according to the specified analytical procedures, the drug substance or drug product must conform to the specified acceptance criteria

03/03/2023

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Proven Acceptable range (PARs)

• Drug substance/Drug Product (Introduction of PARs) ~ ? % ( )

• A closely related idea to the Design Space concept is the notion of Proven Acceptable Ranges (PAR) for a set of process variables. • PAR (ICH Q8) “a characterized range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria”.

Questions and answers: Improving the understanding of NORs, PARs, DSp and normal variability of process parameters

03/03/2023

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