Unlocking Test Method Validation Mysteries

I recently attended a conference where the topic of test method validation sparked an interesting panel discussion. This brought to mind a technical challenge we faced with an instrument tasked with measuring a biological characteristic numerically.

During initial conversations with the Quality Control team, there was concern about acquiring samples at various levels directly from the manufacturer. I pointed out that method validation differs from process validation; it doesn't require samples produced naturally through a process. Instead, we can create samples artificially to represent a range of expected values, ensuring the test method measures them both precisely and accurately.

With this approach, we used a "spiked" lot to obtain numbers on the higher end and mixed different lots to produce samples near the pass/fail threshold. The samples that occurred naturally were typically low and well within the specifications. By utilizing this variety of sample levels, we successfully completed the method validation.

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