gempex GmbH

Validation Service

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`Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.`

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Our Offer
Consulting and staffing support in

  • Process validation
  • Cleaning validation
  • Validation of analytical methods
  • Validation of computerized systems

Our Procedure
We provide advise and support in the form of specialist knowledge and staffing resources in the preparation of individual validation protocols and in the execution of the final validation reports, whereby the your company carries out the validation activities.

Here we also base our work on tried and tested basic concepts and specially developed checklists, which we continuously improve according to the latest developments as well current GMP requirements.

We provide you with basic versions of all SOPs concerning the validation and, together with you, adapt them to your individual requirements.