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Qualification of pharmaceutical processing systems by Testo Industrial Services

Qualification of pharmaceutical processing systems

Jäger GmbH.

Reference

Qualification of pharmaceutical processing systems

at Jäger GmbH, Muggensturm

As an innovative contract manufacturer, Jäger GmbH produces and packages products for notable cosmetics and pharmaceutical companies. The production of several galenic forms such as liquids, lotions, gels, creams, ointments, powders is carried out strictly according to customer specifications with manufacturing permission according to section 13 of the German Medicinal Products Act (AMG). A wide range of different machines, which meet the highest GMP-compliant quality requirements, are available for packaging.

The aim of this project was to integrate the existing qualification documents into a cross-company qualification master plan and to qualify process systems of the entire production area (bulk production and packaging) in a retrospective project in conformity with GMP.

Qualification of pharmaceutical processing systems

Our scope of services

at Jäger GmbH, Muggensturm

  • Conception/consulting in the field of qualification/validation
  • Conception of all qualification measures
  • Structuring of qualification activities by means of the qualification master plan
  • Scheduling and resource management
  • Risk-based qualification management
  • Creation and presentation of system-specific risk analyses
  • Creation of all qualification documents (IQ/OQ/FRQ)
  • Execution and documentation of all qualification tests (IQ/OQ)
  • Calibration/calibration management
  • Consulting in the area of maintenance and repair concepts

More assurance, better service for your GMP compliance

What set us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Testo Industrial Services

Our services at a glance

Your contact

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