Privatsphäre-Einstellungen

Grundlegende GMP-Anforderungen an Packmittelhersteller

Auditing

Frank Böttcher

Wülfing Pharma GmbH, Gronau/Leine

Basic GMP Requirements to Manufacturers of Packaging Materials / Auditing

Regulatory requirements of packaging materials increased during the last years. Therefore it is not sufficient to test packaging materials against the registered specification. The manufacturer of packaging materials should be able to guarantee the requested quality by making suitable efforts in qualification and validation of production processes and valid test procedures. He has to establish a quality assurance system which makes sure that production and testing of packaging materials are in compliance with the EC GMP guideline for pharmaceuticals. Special requirements have to be established to guarantee the quality of processes which are typical for the manufacture of packaging materials.
In process controls replace more and more tests on random samples because they are able to cover 100 % of products. The release of packaging materials is based on one hand on the data and test results which are performed by the manufacturer and on the other hand on tests performed at the pharmaceutical company. The quality control manager of the pharmaceutical company remains responsible for the quality of packaging materials. Therefore it is necessary to establish a sufficient supplier qualification program. Audits are an essentials part of the supplier qualification program. Audits must be well prepared and should follow defined rules. The audit report is necessary to give an overview of the efficiency of the manufacturer of packaging materials. The audit report is the basis to follow up the improvements of the supplier.

Key Words Audit · Good Manufacturing Practices (GMP) · Lieferantenqualifizierung · Packmittelherstellung · Verpackungsmaterialien