Module 9 2024

03/09/2024

Common Scenarios - Comparability

Things change…

● Manufacturing Facility / Manufacturing Process / Analytical Methods/Formulation/ Container/Closure

Change map

● Highlight change and identify what other steps are affected

Risk assess

● Assess potential impact of the change(s) to the product quality, safety and efficacy (FMEA: ICH Q9)

Comparability

● Conduct analytical comparability (ICH Q5E) assessment to demonstrate that the product quality, efficacy and safety are unaffected

Additional Studies:

● Based on residual uncertainty additional nonclinical and clinical data may be required

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Common Scenarios - Transfer

Process / Method Transfer

● Ensure processes/methods are validated at all required GMP test facilities

Approach

● Process: conduct test materials/equipment gap analysis, paper transfer, training, conduct non-GXP engineering test runs first, (one not enough) prepare protocols with scientifically determined specs then execute transfer ● Test Methods: conduct test materials/equipment Gap analysis first, then non-GXP feasibility runs, organise on site training if required, prepare protocols with scientifically determined specs then execute transfer

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