Validation and Calibration in the Life Science Industry

Validation and calibration are a global regulatory requirement for the life science industry. Validation is defined by the FDA as a process that is required to establish documented evidence which provides a high degree of assurance that a specific, system, equipment, computer system or process will consistently meet the requirements and its intended use. In the life science industry all systems, computers, equipment and processes that have GxP impact require validation. Calibration of an instrument is the process of determining its accuracy. The process involves obtaining a reading from the instrument and measuring its variation from the reading obtained from a standard instrument. Calibration of an instrument also involves adjusting its precision and accuracy so that its readings come in accordance with the established standard.

In the life science industry, the following processes and systems are subject to validation requirements

• Computer Systems
• Laboratory Instruments
• Analytical Methods
• Manufacturing Processes
• Manufacturing Equipment
• Shipping
• Cleaning and Sterilization (CIP/SIP)
• Packaging
• Fill and Finish Manufacturing Processes

Calibration of instruments and measuring devices in the life science industry includes the following

• Pressure calibration
• Temperature calibration
• Flow calibration
• Pipette calibration
• Mechanical calibration

Validation and calibration are different; calibration requires assessing the accuracy of instrument results by measuring the variation against a defined standard to determine the relevant correction factors. The equipment is accordingly adjusted to fine tune its performance to tally with accepted standard or specification.

Validation provides documented evidence that a system meets user requirements and its intended use. Validation and calibration are critical regulatory requirements in the life science industry.