When Validation Trumps Verification
In an earlier blog post, I talked about choosing between verification and validation. The decision was based on practical reasons. Yet, there are times when verification isn't possible technically. This is mainly because measuring a product's attribute can damage it. If every item undergoes a destructive test, there'd be nothing left to sell. In Life Sciences, reduced product availability can have health consequences for patients.
In such cases, validation becomes necessary. For instance, with sealing equipment ensuring a contamination barrier, you'd test the contents for bioburden load. However, checking this requires opening the barrier, rendering the product unsellable. Another example is confirming content uniformity in a mixing vessel. Testing the entire content through an assay would dissolve the product, making it unavailable if done for the whole batch. Lastly, testing a freeze-dried product for solubility and particulates by adding water would destroy it, allowing only representative samples to be used. Once you’re testing samples instead of a full batch, verification is no longer applicable.
Although validation can be more complicated than verification, destructive testing sometimes makes validation the only feasible option. Embrace effective validation to safeguard your products, ensuring quality without compromises. Your choice impacts success—validate wisely for thriving products!
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.
