Quality and Certificates

For each of its locations, Schachinger healthcare holds a business license for "the wholesale distribution of medicinal products" according to Section 213, Para. 1 (5) of the Austrian Industrial Code 1994 (Gewerbeordnung), as well as operating licenses according to Section 63 of the Austrian Medicinal Products Act (Arzneimittelgesetz). In 2008, all locations were inspected by AGES Pharmmed.

As a pharma logistics company, we meet the requirements of the AMBO 2009, short for Arzneimittelbetriebsordnung 2009 (Austrian regulation on producers of medicinal products), that are of relevance to wholesalers, in particular with regard to:

  • the operation of a fully functional pharmaceutical quality management and assurance system
  • written process descriptions and work instructions
  • documented regular self-inspections (at least three internal audits per year conducted by external consultants) in order to verify compliance with GMP and GDP principles and guidelines
  • the definition of a "competent person" and of an organizational chart
  • the use of duly qualified staff, and the provision of training courses on an ongoing basis
  • the integration of hygiene, cleaning, and maintenance instructions, and of a pest control program in our quality management system
  • the use of a validated IT system
  • the storage of the products in line with their specification in air-conditioned and/or controlled environments
  • the separation of goods receipt, goods issue, and storage areas
  • Quality Austria certifications to ISO 9001 and 14001

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