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Quality Management

We deliver quality for our customers. Therefore we meet the standards set by national and international legislation as well as specific customer requirements.

Regular authority inspections and independent audits show that we are continually developing and improving our performance.

Our Quality Management systems include:

  • Site Master File
  • Standard Operating Procedures (SOP)
  • Corrective and Preventive Action (CAPA)
    • Change control processes
    • Quality deviation and complaint management
    • Internal quality audits
    • Customer quality audits
    • Authority inspections
  • Equipment Certification
  • Process Validation
  • Employee Training and Qualification

Many customers make use of our service options including:

  • Product release for transport or market sale
  • Product quality reviews
  • Long term storage and in-use stability testing from concept and storage to analysis and reporting in accordance with the ICH-standards.

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© 2019 WAGENER & CO.