Module 3 Presentations

07/05/2024

What are requirements for pharmaceutical packaging?

“The container is so designed that the contents may be removed in a manner appropriate to the intended use of the preparation. It provides a varying degree of protection depending on the nature of the product and the hazards of the environment , and minimises the loss of constituents . The container does not interact physically or chemically with the contents in a way that alters their quality beyond the limits tolerated by official requirements.” (Ph. Eur. – 3.2)

The Organisation for Professionals in Regulatory Affairs

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What are requirements for pharmaceutical packaging?

“3.1. Materials used for the manufacture of containers The materials described in this chapter are used for the manufacture of containers for pharmaceutical use . … Materials and polymers other than those described in the Pharmacopoeia may be used subject to approval in each case by the competent authority responsible for the licensing for sale of the preparation in the container.” (Ph. Eur. 3.1)

The Organisation for Professionals in Regulatory Affairs

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