Module 9 2024

03/09/2024

Common Scenarios – E&L

Toxic E&L Identified ● Root cause analysis

– Confirm test method results are valid – Characterise to identify source ● Address root cause (may need to change label adhesive / location / container closure /process components) ● Ensure suitable methods are developed and validated to monitor levels of high risk leachables for the intended hold period.

The Organisation for Professionals in Regulatory Affairs

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Common Scenarios – Release Data

One of the batches shows different data to other batches

● Root cause analysis – Confirm test method results are valid – Review BMR – any atypical steps – Check container and associated packaging – Shipment excursion (not just condition / duration/ handling) ● Need to demonstrate you have characterised and understood cause of differences ● Is this batch representative of your process? ● Process consistency

The Organisation for Professionals in Regulatory Affairs

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