Medical gases enter the human body directly or are used on it. They must therefore meet particularly high quality standards.
To ensure that this happens, Messer complies with the strict Good Manufacturing Practice guidelines issued by the European Commission. The required composition of medical gases is defined in the European Pharmacopoeia, that is to say, in the relevant monographs. Strict adherence to these monographs is, of course, one of the requirements for Good Manufacturing Practice (GMP).
While quality management systems such as the well-known ISO 9001 system create good foundations, they are no replacement for adherense to the GMP guidelines. “GMP adopts a comprehensive approach”, explains Matthias Thiele, Vice President Medical an Pharma Gases at Messer. “For example, it also includes organisational structures and personal responsibility”.
Thus, for example, the heads of production and quality control must be two different persons. A Qualified Person (QF) ist responsible for personally approving each batch of medicinal products. The QP must have a certificate of competence an be registered with, and recognised by, the relevant authority.
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