Module 3 Presentations

07/05/2024

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)

The Organisation for Professionals in Regulatory Affairs

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How to define/specify the desired quality?

Requirements are defined during the development phase and documented in specifications The requirements may change during the lifecycle of the packaging material  E.g. due to new requirements from the pharmacopeia, from laws, due to experience in the market (complaints) or due to change of the pharmaceutical product or the manufacturing process A regular review of the specification, especially against “the state of the science and technology”, is recommended

The Organisation for Professionals in Regulatory Affairs

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