Validation & Calibration

"Can you provide me a definition of Validation vs. Calibration?"

A customer reached out to me asking a general question that I've heard many times in the past and so I thought I would post this blog to help answer the question.

Understanding the basic differences between validation and calibration.

Validation is the documented act of demonstrating that a procedure, process, and activity will consistently produce a result meeting pre-determined acceptance criterion or in other words lead to your intended or expected results. Our industry's most common ways of establishing evidence or documenting test results are through Protocols. Protocols, such as IQ, OQ, PQ’s, along with essential design and planning documents – URS and VMP’s, for example.

Why is this essential? The FDA requires validation or documentation that a specific process will consistently produce a result that meets specifications and quality attributes. Without this documentation, you are functioning at risk with compliance issues.

Calibration is specifically referred to measurement devices, instruments and tools that record, monitor, and control environmental conditions or parameters. Calibration can be defined as a process that demonstrates, a particular instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. This process includes the adjustment of any instrument to bring it into alignment with the standard.

Taking measurements with any instrument used in a GxP process requires calibration to ensure the accuracy of the measurement. Instruments that record, monitor, control critical environmental variables require calibration. You must carry out instrument calibration on a regular basis to make sure that they produce accurate results.

References: 21 CRF parts 210 and 211 and 820

To learn more about protocols or general validation services please contact me directly at [email protected]