GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process. To ensure that the products are absolutely fit for intended use, the company has to demonstrate in a documented form that the processes, methods, tests, activities and equipments they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions.

We provide high quality qualification services, based on the industry trends and best practices. Our highly experienced staff can work with your operations and quality groups to generate protocols, facilitate execution, generate and collate necessary information and formalize the reports.

The above activities can also be extended to Perspective, Retrospective, Concurrent and Re-validations

Equipment Qualification (DQ, IQ, OQ & PQ)
HVAC + LAF systems
Temperature / RH mapping
Water systems
Engineering equipment (Nitrogen / Air, DI water, steam systems)
Process validations
Cleaning validations
Microbiology – Related validations
Transport validations
Others