The validation of manufacturing processes and also validation of cleaning procedures present complex, time consuming and cost-intensive tasks to any pharmaceutical company. Due to their cardinal impact on drug product safety, both aspects are important and current focal points in authority GMP surveillance.

Rooted in years of experience in the areas of process and cleaning validation, we are well acquainted with the binding requirements and the expectations of authorities. We encourage You to take advantage of our expert knowledge. We are happy to support and guide You through various tasks and will help You to get Your questions answered:

  • Definition and optimization of validation concepts (manufacturing processes and cleaning procedures), including Your validation master plan
  • Risk analysis in order to determine validation gaps and needs, risk evaluation as a scientific basis for bracketing within cleaning validation
  • Strategy development for minimization of time and effort for process and cleaning validation
  • Introduction of the Continued Process Validation / Ongoing Process Validation approach (European approach)
  • Introduction of the FDA validation approach
  • Drafting of master SOPs for process validation and cleaning validation
  • Planning, organization and realization of process and cleaning validation
  • Training of employees on all aspects of process validation and cleaning validation