Module 3 Presentations

07/05/2024

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.” (Annex 1 to Directive 2001/83/EC amended)  Documents to describe the quality of the packaging materials

The Organisation for Professionals in Regulatory Affairs

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In a nutshell: Quality of pharmaceutical packaging

Summary The Quality of a pharmaceutical packaging needs to be demonstrated Quality can be demonstrated by ensuring compliance with the compendial quality standards or by establishing an own quality standard (in-house specification)

The Organisation for Professionals in Regulatory Affairs

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