Qualification & Validation
Pharmaceutical companies have a number of quality and process challenges. Compliance to industry norms like cGMP requires streamlined processes, quick decision-making, an effective risk management strategy and strong documentation.
CN Water’s systematic approach t- enables organizations to bring their water generation processes under the purview of Total Quality Management. Our team of trained service engineers carry complete qualification of - water systems, covering Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) . Conforming to highest standards of quality, we adhere to the standards of 21 CFR , CSV, Traceability matrix and Audit trails. And provide comprehensive training to service engineers to follow all SOPs and ensure smooth operation of the systems.
We follow a four-step process to system qualification and validation:
- Define metrics to evaluate system performance at various stages (e.g. feed water, potable water generation, WFI & steam generation, etc.). We follow industry benchmarks like cGMP to define quality metrics.
- Identify process gaps and potential water quality issues early and take proactive steps to address them.
- Perform system health check-ups and troubleshooting to breakdown maintenance.
- Routinely collect data from installations and address quality gaps at the earliest.
We ensure complete documentation and compliance with all necessary guidelines like cGMP, GAMP, USP and Eur. Ph. Requirements and as per ISPE Engineering Baseline Guide, Vol. 4 "Water and Steam Systems".