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.
