Module 3 Presentations

07/05/2024

Proof of Suitability • has to be provided during the approval procedure What are requirements for pharmaceutical packaging?

• has to be shown individually (per specific container and drug) • extend of the documentation depends on the specific case (e.g. complexity of the product, risk of the formulation/application)

The Organisation for Professionals in Regulatory Affairs

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Risk based classification of container closure systems

Source: FDA’s Guidance for Industry “Container Closure Systems for Packaging of Human Drugs and Biologics” Docket Number:FDA-1997-D-0145

The Organisation for Professionals in Regulatory Affairs

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