Qualifications are
carried out in accordance with the good practice guidelines and documented
evidence that the manufactured equipment, the facility or the process system is
suitable/ready for the intended use and fulfils the user requirements.
The activities of
the department refer to the implementation of IQ/OQ tests in the scope of FAT
and SAT tests as well as the calibrations and user training after completion of
SAT testing.
Our approach to
equipment qualification aligns with V Model, GAMP, ISPE, and ASTM E2500
guidelines, where we prioritize validation support tasks and documentation
based on their criticality for end product quality. We then tailor these
activities to meet customer requirements, accounting for risk and complexity.
Installation and
Operational Qualification of equipment, Process Qualification and Validation
for consistency and repeatability, is of key importance in the biopharma
industry.
With a systematic
approach to controlling the various stages of project life cycle from design,
development, and production to testing, every aspect of the project is well
documented as per cGMP guidelines. We also perform Computer System Validation
as per 21 CFR Part 11 guidelines.