Register Login

Validation: Multiple Lots

George received this question for our quality assurance experts. When validating a procedure, do you work with a single lot or multiple lots?

Comments (1)
Apr 9, 2019 4:23pm

Most institutions purchase
Most institutions purchase designated single lots of reagents to use with their instrumentation. Those with multiple sites try to not have a great deal of variation with their reagent/instrument in their laboratories. Why then would you add another variable of a second lot of reagents to perform a method validation? This would only create an expensive time and cost issue that seems to be superfluous. The variable would be the specimens that would test the system to compare with intra or inter-laboratory test results.

Leave a Reply