Valicare - Re-Qualification & Re-Validation

GMP compliant use of critical pharmaceutical equipment and processes requires re-qualification and re-validation on a regular basis.

These critical processes and systems in manufacturing and quality control areas concern predominantly sterilisation and bio decontamination.

On the basis of initial qualification or validation the most critical test parameters are periodically – and usually in reduced scope - checked in re-qualification and revalidation approach.

Systems and processes on which Valicare especially proposes its services are:

Autoclaves, dry heat sterilizers, CIP/SIP systems, depyrogenisation tunnel, decontamination cycles of isolators and active air lock systems

Furthermore Valicare prepares the GMP compliant documentation for aseptic filling process validation via media-fills

Valicare performs all the tests by means of qualified & calibrated instruments and documents the results, and the deviations including suggestions for their solution. We also prepare the final reports after successful qualification or validation for your approval.