Module 3 2019

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