Module 3 2019

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