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Construction of a new logistics centre - GxP-compliant qualification and validation by Testo Industrial Services

Construction of a new logistics centre - GxP-compliant qualification and validation

Grieshaber Logistics Group AG.

Reference

Construction of a new logistics centre - GxP-compliant qualification and validation

at Grieshaber Logistics Group AG, Rheinfelden

Grieshaber Logistics Group AG with its headquarter in Bad Säckingen is an internationally focused contract logistics service provider with seven state-of-the-art logistics locations in the EU and Switzerland. The newest site in Rheinfelden offers GxP-compliant storage and packaging of pharmaceuticals in a 25,000 m² area. These are stored at either < -18 °C, 2-8 °C or 15-25 °C.

The aim of the project was to create an integrated concept for GSP compliance together with Grieshaber Logistics Group AG, to get this established and to implement the qualification and validation measures derived from this. In addition to state-of-the-art requirements, all quality assurance measures should meet the relevant requirements in the area of EU GxP legislation and be “FDA audit-proof”.

GxP-compliant qualification and validation

Our scope of services

at Grieshaber Logistics Group AG, Rheinfelden

  • Risk-based qualification management from the design phase
  • Documentation in customer layout
  • Creation of qualification schedules and performance of all tests: Validation Project Planning (VPP), Risk Analysis (RA), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Execution of climatic mapping with a total of 563 measuring points and derivation of climatic profiles
  • Realisation of summer and winter mapping (PQ phase) and stress tests
  • Support and consulting in the field of GSP-compliant qualification
Storage qualification by Testo Industrial Services
  • Conception, planning and layout of the GxP-compliant monitoring system
  • Preliminary calibration of the loggers in the accredited laboratory according to process-oriented tolerances and subsequent delivery
  • Measurement of transmission paths and definition of the installation sites
  • Installation of radio probes for positioning the measuring points far from any Ethernet connection
  • Performance of the Site Acceptance Test (SAT)
  • Positioning of measurement probes based on the results of climatic mapping
  • Establishment of an automatic alarm concept when limit values are exceeded
  • Continuous recording of measuring values in the event of a power failure with storage of up to 6000 values per channel
  • Convenient enhancement of the monitoring system at any time
  • Extensive analytical options with the validatable Saveris CFR software
Assembly & commissioning of the Saveris monitoring system by Testo Industrial Services
  • Risk-based design specification taking into account structural, regulatory and functional monitoring requirements
  • Process-related definition of tolerances for the logger calibration
  • Risk-based definition of the scope of validation, taking into account the customer's IT environment and its requirements. The results were presented and developed in a joint FMEA workshop.
  • Validation performed in accordance with GAMP®5 including software whitebox tests
  • Configuration tests on the system in accordance with software category 4 (configurable standard software)
  • Development and implementation of a modular documentation system for efficient integration of new storage areas into validation (change management)
Calibration & validation of the monitoring system by Testo Industrial Services

GxP-compliant qualification and validation

The result

at Grieshaber Logistics Group AG, Rheinfelden

“Especially in such a large project with several parties and different suppliers, complete project coordination and agreement at short notice is essential.  Testo was a great example in this respect, and always available for speedy clarification. We were very impressed by the flexibility with which Testo responded to changing circumstances and project schedules. The procedure and all qualification and validation activities were technically flawless, which, incidentally, was verified once again in an important audit after completion of the project.”

Edgar Steinke, Technical Director at Grieshaber Logistics Group AG

Conversation in front of the Grieshaber Logistics Group AG building

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

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