Module 3 2019

How to prove the quality?

“3.2.2.7. Container and closure of the finished medicinal product A description of the container and the closure system(s) including the identity of each immediate packaging material and their specifications shall be provided. The specifications shall include description and identification. Non-pharmacopoeial methods (with validation) shall be included where appropriate.”

→ Documents to describe the quality of the packaging materials

The Organisation for Professionals in Regulatory Affairs