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.
Unlock your project's potential. Share your insights or challenges on LinkedIn or Facebook!
About Brayearst Validation Consulting
Brayearst Validation Consulting leverages Six Sigma methodologies to provide targeted validation services for the life sciences industry. We specialize in process, cleaning, software, and analytical test method validation, ensuring compliance with FDA requirements while optimizing operations for efficiency and quality. Our team combines technical expertise with a deep understanding of regulatory standards to deliver process-driven validation documents that withstand rigorous auditor scrutiny. From strategy development to study execution, we empower our clients to achieve operational excellence and bring high-quality products to the market with confidence.
