1.To Prepare and review of following documents:
2.To Prepare Master documents: Validation master plan, cleaning validation master plan and Protocols & Reports.
3.To Prepared and perform cleaning validation protocol, cleaning validation matrix and cleaned equipment hold time & dirty equipment hold time study.
4.To perform Equipment qualification (manufacturing and packing equipment's).
5.To perform Temperature and RH mapping study of storage area.
6.To perform utility qualification compressed air, nitrogen gas and purified water system.
7.To perform facility qualification, HVAC qualification and periodic HVAC validation.
8.Facing managing regulatory/customer/internal inspection. Providing compliance to identified shortcoming as per requirement.