Qualification and Validation
We focus on best quality
Good Manufacturing Practice (GMP) is the basis for any effective quality management. Among other things, it defines binding rules for the manufacture of pharmaceutical, cosmetic and consumer healthcare products.
Our GMP-compliant quality management system ensure the required product quality for you. Qualification and validation are elementary components. With the qualification we demonstrate that all impacts on the product quality (e.g., space, machines, devices) function as required and provide the expected results.
Ensuring that it doesn't become critical for you
The risk analysis is the basis of the validation. We set measurable requirements, define acceptance criteria and process steps as well as critical parameters and measures to minimize risk. We create functional GMP risk analyses and moderate them at your site. Our acceptance tests are documented with test protocols and reports including deviation lists. We provide you with process and instrumentation diagrams or process indicated diagram as well as material, surface and welding documentation for components that come into contact with products, media or packaging.
We test, qualify and verify
- Testing the technology used
- Testing of hardware and software
- Documentation and reports
- Specifications for functions, design and technology
We measure quality
- Three-point calibrations
- Measurements on CIP-SIP systems
- Temperature recordings to document the log rate
- Checking the cleaning effect
- Measurements on the integrated clean air systems