Module 3 2019

What are requirements for pharmaceutical packaging?

“ Only substances and the containers and outer packaging , in so far as they come into contact with the medicinal products, and only pharmaceutical forms which are in compliance with recognised pharmaceutical rules, may be used in the manufacture of medicinal products. ” (Example from §55 of the German Medicinal Products Act)

→ The quality of containers needs to be proven

“Recognized pharmaceutical rules” are represented by the quality standards as defined in the Pharmacopeia’s, e.g. Ph. Eur. 3.2 “Containers”

The Organisation for Professionals in Regulatory Affairs