Module 3 Presentations

07/05/2024

How to prove the quality?

yes

no

Ph. Eur. 3.2 Compliance?

“The specifications for containers in 3.2. Containers and subsections have been developed for general application to containers of the stated category, but in view of the wide variety of containers available and possible new developments, the publication of a specification does not exclude the use, in justified circumstances, of containers that comply with other specifications, subject to approval by the competent authority. ” (Ph. Eur. 1.3.1)

Justification and documents to prove the quality

Certificate of Analysis

The Organisation for Professionals in Regulatory Affairs

15

How to prove the quality?

yes

no

Ph. Eur. 3.2 Compliance?

“The specifications for containers in 3.2. Containers and subsections have been developed for general application to containers of the stated category, but in view of the wide variety of containers available and possible new developments, the publication of a specification does not exclude the use, in justified circumstances, of containers that comply with other specifications, subject to approval by the competent authority. ” (Ph. Eur. 1.3.1)

NOTE: For Containers made of plastic documents are required according Guideline on Plastic Immediate Packaging Materials (CPMP/QWP/4359/03)

Justification and documents to prove the quality

Certificate of Analysis

The Organisation for Professionals in Regulatory Affairs

16