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 management oversight.
CN Water’s systematic approach to high purity water system implementation and maintenance enables organizations to bring their water generation processes under the purview of Total Quality Management. Our team of trained service engineers carry our complete qualification of your water systems, covering Installation Qualification (IQ) as well as Operational Qualification (OQ) and Performance Qualification (PQ). We provide comprehensive training to service engineers to 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,.