Metochem-Pharma GmbH – Arzneimittelbetriebsordnung realised successfully
When AMBO 2005 got into force in Austria (and the new AMWHV in Germany respectively), EG-directives regarding production, monitoring and bringing drugs (and active ingredients respectively) onto the market, have been implemented into national law. This triggered checks and actualisation in terms of quality assurance measures in a number of pharmaceutical companies.
An exemplar for the successful implementation of these increased standards is the cooperation between METOCHEM-PHARMA GmbH und VTU Engineering. Vienna’s METOCHEM-PHARMA GmbH is one of the leading suppliers of herbal drugs and is enforcing the production of innovative drugs available without prescription, which are sold in Austrian chemist shops.
Back in 2004 the whole production was subject of a risk assessment based on GMP checklists. Results of this assessment initiated the first measures. These joint activities lead to the actual validation master plan and site master file, a QM-Management adjusted to customer and legal requirements, to partly upgraded production components, to transparently documented and qualified plant status and to a newly structured and rounded off system of standard operation procedures and application documents.
Regarding implementation of defined measures, financial and manpower resources of METOCHEM-PHARMA GmbH have been considered at its best.
The experiences showed clearly, that an offensive approach to legal and economic requirements on the one hand and an active cooperation between client and GMP-Consultants on the other hand leads cost effective and well directed to a sustainable an continuous quality increase.
The result of this problem specific cooperation with VTU was a successfully passed routine authoritiy audit in spring 2007.
