Module 14 2022

24/03/2022

Question: what are the safety implications with using this packaging component? US concept for pharmaceutical packaging.. DEGREES OF CONCERN…

Question what is the likelihood of an interaction?

…for devices – will this impact PERFORMANCE?

Interactive Session

The Organisation for Professionals in Regulatory Affairs

21

Pharmaceutical PACKAGING matrix of concern

The higher the score, the more data are needed to prove the suitability of the packaging…. A SIMILAR TYPE OF ALGORITHM CAN BE APPLIED TO CERTAIN MEDICAL DEVICES

Interactive Session

The Organisation for Professionals in Regulatory Affairs

22

11