Module 3 Presentations

07/05/2024

What are requirements for pharmaceutical packaging?

3.2.2.2. Pharmaceutical development g) The suitability of the container and closure system used for the storage, shipping and use of the finished product shall be documented. A possible interaction between medicinal product and container may need to be considered.” (Annex 1 to Directive 2001/83/EC amended)  The suitability of containers needs to be proven

The Organisation for Professionals in Regulatory Affairs

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What are requirements for pharmaceutical packaging?

Proof of Suitability “3.2.P.2.4 Container Closure System (name, dosage form)

The suitability of the container closure system (described in 3.2.P.7) used for the storage, transportation (shipping) and use of the drug product should be discussed. This discussion should consider, e.g.,

choice of materials

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protection from moisture and light,

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• compatibility of the materials of construction with the dosage form (including sorption to container and leaching) • safety of materials of construction, • and performance (such as reproducibility of the dose delivery from the device when presented as part of the drug product).“ (Notice to Applicants, Volume 2B incorporating the Common Technical Document (CTD))

The Organisation for Professionals in Regulatory Affairs

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