Privatsphäre-Einstellungen

Lieferanten-Auditierung - Qualitätssicherung bei Primärpackmitteln aus Glas für pharmazeutische Produkte

Grundlagen und ausgewählte Aspekte zur Auditierung von Glasröhren-Herstellern

Alfred Breunig und Dr. Peter A. Schröder

MGlas AG (MG), Münnerstadt

Supplier Auditing - Quality Assurance concerning Primary Packaging Material Made of Glass for Pharmaceuticals / Basics and some important aspects of the auditing of glass tube manufacturers

MGlas AG (MG) manufactures practically 100 % of its primary packaging material made of tubular glass for the pharmaceutical industry. MG produces various types of containers, mainly injection devices (parenterals). The product range comprises syringes, cartridges, vials, ampoules as well as a number of special containers. Some products are manufactured for medical-diagnostic purposes.
Glass tubes are therefore the sole raw material used at MG and the qualification of glass tube manufacturers is the definite focus of supplier audits. This paper mainly addresses the performance of audits at a glass tube manufacturer. Details on general chemical and mechanical properties were added where relevant for the selection and substantiation of the chosen audit aspects.
One of the most important corporate goals at MG is the incorporation of GMP-relevant requirements into production and control of primary packaging material for medicinal products. This aspect of company policy is naturally also included in the requirements for the respective sub-suppliers.

Key words Audit-Management · Glasbehältnisse für Parenteralia · Glasröhren · Lieferanten-Audits · Pharmazeutische Packmittel aus Glas · Primärpackmittel aus Röhrenglas