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: firstname.lastname@example.org
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.
Key words Plastic immediate packaging • CPMP/QWP/4359/03 • Interaction studies • Migration studies • Herbal preparations • Liquid medicinal products
pharmind 2007, Nr. 8, Seite 979