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Qualification & Validation

In the production of pharmaceutical products, strict regulations are intended to ensure the quality of the medicines produced and thus the safety and effectiveness for patients.

The review and assessment of the facilities and systems (qualification) and the processes and methods (validation) is an integral part of the Good Manufacturing Practice (GMP) guidelines.

In our consulting services we focus on validation of

  • cleaning procedures

  • manufacturing processes

  • methods

and during qualification on

  • devices

  • supply systems

  • clean rooms

We support you with

  • creation/review of documents (SOPs, master plans, risk analyses, plans, reports)

  • review of existing systems / GAP analyses

  • setting up and implementing new systems/training staff

  • planning, coordination and implementation of qualification and validation activities

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