Module 9 2024

03/09/2024

Common Scenarios – Process Consistency

Process shows inconsistency

● Product quality is variable and trending indicates high risk of batch failure

• Optimise/develop process to minimise variation

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Conduct process characterisation: – Risk assess to assign CPPs that can be measured with CQAs (FMEA: ICH Q9) – Characterise higher risk CPPs – Define NoR in which risk of failure is minimised

The Organisation for Professionals in Regulatory Affairs

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Common Scenarios – Method Validation

Method does not detect differences during forced degradation studies ● Method is not valid for stability use ● Use alternative or develop and validate new method ● Pull retains and test those using new method (with a reference) ● Justify cross over

Methods not fully validated during PPQ

● High risk strategy: post PPQ at-risk validation

The Organisation for Professionals in Regulatory Affairs

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