Process Validation

Implementing GHTF Guidelines.

Missing or insufficient validation of manufacturing processes is one of the most common reasons for warning letters from FDA inspections. Also as part of the ISO 13485 certification process, validation is playing an increasingly important role.

The FDA's definition of Process Validation:

“Process validation is establishing 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 characteristics.“

Our services include:

  • Management of validation projects
  • Definition and documentation of process requirements and process parameters
  • Creation of a validation plan
  • Implementation and documentation of risk analysis
  • Structuring and support of validation studies
  • Documentation of the results in the validation report

The Capamed Advantage:

  • Your validation project is carried out by experienced GMP consultants
  • We provide the documented evidence that a process can reproducibly provide the required results
  • Your documents (validation plan, risk analysis, validation report) comply with regulatory requirements