Privatsphäre-Einstellungen

Testing of and Specifications for Plastic Immediate Packaging Materials

Interpretation of the Note for Guidance CPMP/QWP/4359/03 for active substances and medicinal products of complex composition

René Roth-Ehrang^1,6, Thomas Krieger^2,6, Frank Poetsch^3,6, Diethelm Weltin^4,6, Ehrhard Anhalt^5,6, Barbara Steinhoff^5,6

¹ Finzelberg GmbH & Co. KG, Andernach (Germany)
² Biologische Heilmittel Heel GmbH, Baden-Baden (Germany)
³ SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG, Bruckmühl (Germany)
⁴ CAU Analytik / Dr. Graner & Partner GmbH, Dreieich (Germany)
⁵ Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn (Germany)
⁶ on behalf of the BAH Working Group on Plastic Immediate Packaging Materials

Corresponding author: Dr. Barbara Steinhoff, Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Ubierstr. 71–73, 53173 Bonn (Germany), e-mail: steinhoff@bah-bonn.de

The Note for Guidance CPMP/QWP/4359/03 demands extensive testing of plastic immediate packaging materials, particularly in case of liquid active substances and medicinal products. This includes general information, specifications and results of extraction and interaction studies. The following contribution is intended to provide the applicants with guidance on the practical implementation of the Guideline. It can be shown by own examinations on liquid herbal preparations that for testing and assessing of plastic immediate packaging materials the methods and limits set for foodstuffs can be used. As a consequence the safety of the used plastic material can be sufficiently proven by submission of a certificate on the compliance of the final packaging with foodstuff legislation.

Key words Extraction studies • Herbal preparations, liquid dosage forms • Interaction studies • Plastic immediate packaging materials