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Quality and certainty
Licensing & Authorisation
Our imported medicinal drug products are subject to
the relevant legal regulations and standards set by
European and German laws relating to medicinal products.
Every drug sold by axicorp is, as prescribed by law,
examined and certified by the Federal Institute for
Drugs and Medicinal Products (BfArM) or the Paul-Ehrlich-Institute
(PEI), to the therapeutic qualities as well as adherence
to the legal requirements.
Quality Assurance:
axicorp Pharma GmbH is a pharmaceutical entrepreneur,
in the sense of the AMG and is subject to the legal
monitoring of the responsible federal and state authorities.
Drug safety has the highest priority. A strict internal
control system safeguards the following of all legal
regulations. With the introduction of the quality-standard
DIN EN ISO 9001:2008, the axicorp Group has additionally
subjected itself to a quality assurance system complying
with the most modern industry standard.
Purchasing:
The axicorp Pharma GmbH exclusively purchases proven
original products from selected, qualified and regularly
audited wholesalers of EU member states. They are also
subject to the control of the relevant authorities.
Production:
The production is, obviously, in accordance with the
relevant legal restraints. The packaging, marketing
and manufacturing of the products, is carried out by
personnel trained according to the EU-GMP-Standards
(Guidelines for Good Manufacturing Practice). Accordingly,
for every step there are firm detailed written handling
and testing rules (Standard Operation Procedures). Our
Head of Production and Quality Control (qualified person)
is answerable for adherence to the rules.
The packaging material is exclusively sourced from
certified suppliers or made by ourselves. Speed, care
and a permanent quality control are also the highest
requirements here.
The adherence to legal regulations is, of course, also
monitored through regular audits by the relevant regional
authority (Darmstadt regional council).
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