The validation process is documented evidence, which provides a high degree of assurance of the expected results and has pre-determined compliance. Term validation is widely used in the pharmaceutical industry. This term comes from the word “valid or validity” which means “legally defined.” The concept of validation was first proposed by the Food and Drug Administration (FDA) in the mid-1970s to improve the quality of medicines. Since a wide variety of procedures, methods or activities are validated to check and improve their quality.
Our validation scope includes Autoclaves, Oven, Sterilization equipment, sterilizing tunnel and sterile filling systems Freeze-dryer and other pharmaceutical equipment.
Utility Systems Validation Scope includes HVAC System, Purified water Systems, WFI Water Systems, Clean Steam Systems, Clean in Place Systems, Steam in Place and Special Gases Systems.
Operational qualification ensures that installed equipment/instrument will function perfectly according to its operation specification in the mention environmental conditions. It also checks that the equipment function perfectly to meet pre-assigned performance criteria and ensure how the testing results are recorded. The purpose of the operational qualification is to make sure that all the dynamic conditions well comply with original (URS) design. For verification, it includes traceable electrical stimulators and standards to verify that the equipment is handled correctly as required.