Module 3 2019

In a nutshell: Suitability of a container closure system

Summary

• The suitability of a container needs to be demonstrated

• Extend of documentation needed for the proof of suitability depends on the risk of the product (which is mainly depending on the route of administration and the dosage form) • Beyond the quality related documentation (General information, Specification) the suitability related documentation is needed (e.g. Extractable/Leachable studies, Interaction studies and toxicological assessments)

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