By Shane Hill
Confidence, reliability—ultimately peace of mind. In short, this is the takeaway following an analytical test method validation.
Do you work in pharmaceuticals, cosmetics, or the environmental realm? All of these fields, and more, benefit greatly from the method validation process. While initially only a mused measure proposed by minds at the US Food & Drug Administration to enhance the integrity of pharmaceutical drugs in the 1970s, it rapidly became a codified and collective effort to improve general processes in manufacturing. Supply chain elements such as product filling and equipment sterilization caught immediate attention and were subjected to a validation metric whereby consistency of execution was paramount. Soon after manufacturing yields were tightened and made more reliable, the eyes at FDA deemed the validation process applicable to the granular level of characteristic tests for sample analysis techniques such as particle size distribution.
Test validation began to incorporate elements from the engineering world, such as the concept of “gauge R&R,” or more broadly termed, a gauge repeatability and reproducibility systems approach. In equipment design, being able to repeat a blueprint within tight specification and moreover reproduce it at another manufacture site was crucial. This same concept was extended to sample material testing in a wide variety of applications.