Module 3 2019

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

Often an attribute will remain on the specification (complies if tested)

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