Qualification and validation

High quality is our first priority

Good Manufacturing Practice (GMP) is the foundation of effective quality management – and includes binding rules for the manufacturing of pharmaceutical and consumer healthcare products. Our GMP-compliant quality management system guarantees high product quality. Qualification and validation are fundamental elements of this system. The qualification process confirms that all influences on product quality (such as facilities, machinery, equipment) operate as prescribed and produce the expected results.

Preventing critical situations

Validation is based on risk assessment. We specify quantifiable requirements, define and measure acceptance criteria, critical parameters and process stages in order to minimize risk. We draft GMP risk assessments and present them to you on site. All of our acceptance tests are well-documented with test protocols and reports, including deviation lists. Other materials include instrumentation diagrams and schematics, as well as documentation for materials, surfaces and welding for components that come into contact with products, media or packaging.

We test, qualify and validate

  • Inspection of installed technology
  • Inspection of hardware and software
  • Documentation and reports
  • Function, design and technology specifications

We measure quality

  • 3-point calibration
  • Measuring on CIP-SIP systems
  • Temperature recording for verifying the log rate
  • Monitoring cleaning effects
  • Measuring of integrated clean air systems