Our quality management ISO 9001

Quality

Quality is multifaceted. It is perceived and viewed differently from person to person, country to country, and company to company. The different concepts of quality are illustrated and documented in the various standards and guidelines.
Due to its significance along the entire value chain, the quality of the logistics system has a major impact on a company’s efficiency. Consequently, a holistic, integrated approach to the concept of quality is vital. Assurance of high quality standards thus has to be binding and ensured by all parties involved in the process, along the entire supply chain.

As a contract logistics service provider, we are fully aware of the responsibility we have to our customers. We are committed to high quality standards, and are uncompromising when it comes to meeting them. Customer satisfaction is the internal benchmark for the quality of our products and services.

Our concept of quality, which is firmly ingrained in our corporate philosophy, is not limited to products and process flows that have already been entrusted to us. For us, quality begins with the first customer contact, includes all of the performance and service requirements specified by our customers, and is reflected in professional project management and in the course of our daily work.

In our ongoing efforts to optimise the quality of our services and performance, we continuously monitor the economic feasibility, safety, reliability, effectiveness and efficiency of our processes – aligned with the quality and service standards our customers demand – and audit them to identify any potentials for improvement.

We expect each and every staff member to be committed to the consistent pursuit of excellence. Consequently, it goes without saying that all of our employees take a quality-oriented approach to our services and products.

Valuable components of our quality management system:

  • Our quality management system is based on 23 quality elements
  • Annual documentation and communication of our company-wide quality objectives
  • Identification and evaluation of quality indicators
  • Effective and appropriate CAPA management
  • Comprehensive audit system: Regular self-assessments, supplier audits, customer audits and audits performed by authorities
  • Validated, electronic document management and training system (SOP Guard)
  • Relevant employee training programmes to increase process safety
  • Customer-related process risk analyses (FMEAs), which are discussed on a regular basis
  • Efficient deviation management (deviations are recorded in special reports, known internally as AUBs)
  • Access control systems
  • Use of highly effective pest control systems
  • IT and technical facilities are validated in accordance with our validation master plan (VMP)

Our permits and certifications:

  • DIN EN ISO 9001:2015
  • DIN EN ISO 14001:2004
  • DIN EN ISO 13485:2016
  • Authorisation to manufacture pharmaceutical products for human use pursuant to section 13 AMG (German Medicinal Products Act)
  • Import authorisation pursuant to section 72 AMG (German Medicinal Products Act)
  • Confirmations of compliance with GMP (GMP certificates) by the respective regional councils
  • Authorisation to wholesale pharmaceutical products pursuant to section 52 AMG (German Medicinal Products Act)
  • Certified to SQAS (Safety and Quality Assessment Systems)
  • HACCP registration
  • FDA registration
  • Regulated Agent pursuant to EU directive and Luftsicherheitsgesetz (LuftSiG)
Porträt Simone Ferrante - Ansprechpartnerin Quality & Regulatory Affairs

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Quality & regulatory affairs
Simone Ferrante

+49 7761/9215-140

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