Privatsphäre-Einstellungen

Limits and Options in the Implementation of the EMEA Guideline CPMP/QWP/4359/03 on Plastic Immediate Packaging

Rene´ Roth-Ehrang and Frauke Gaedcke

Finzelberg GmbH & Co. KG, Andernach (Germany)

Korrespondenz: Rene´ Roth-Ehrang, Finzelberg GmbH & Co. KG, Koblenzer Str. 48−56, 56626 Andernach (Germany), e-mail: rene.roth-ehrang@finzelberg.de

Rules on plastic packaging materials being used as immediate packaging for active substances and medicinal products are given by the Guideline CPMP/QWP/4359/03 and are relevant for marketing authorisation. Especially for liquids different studies are required for the demonstration of irrelevant interaction of plastic packaging materials and the content. Unfortunately, neither test conditions or acceptance criteria are given by the guideline, nor are the necessities of complex mixtures e.g. herbal medicinal products taken into consideration.
However, the guideline does refer to the legislation for foodstuff, for which detailed information concerning test conditions, methods and limits is given. Therefore the question arises whether these requirements given by the foodstuff directives can sufficiently be transferred to medicinal products and active substances. In the following contribution, many arguments are brought forward.

Key words Plastic immediate packaging • CPMP/QWP/4359/03 • Interaction studies • Migration studies • Herbal preparations • Liquid medicinal products