Choose Wisely for Quality!
Today, I want to explore a topic I discussed at the recent PDA capital area chapter meeting on Tuesday, April 22. When you have a manufacturing process regulated by GMP standards, a decision often arises between using verification to document performance or opting for validation. Sometimes, the choice can be a practical one as both options have their advantages.
Let's consider an example from my experience. When weighing a chemical composition dispensed into containers, the decision between verification and validation becomes important. In verification, with larger quantities and fewer units produced, the scale can print the exact result for each container. These printed results become part of the batch history record available for audits.
On the other hand, in validation, where there are smaller quantities and more units produced, documenting each weight individually becomes impractical. Imagine trying to keep track of hundreds of documented weights – it would be a logistical challenge. This is where process validation plays a vital role. It provides documentation of how the filling process operates under specific controls. This documentation becomes crucial when facing audits or inspections.
Making informed choices between verification and validation is key. Pick wisely to ensure top-notch quality and compliance. Act now for manufacturing excellence.
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.
