FDA & ISO: A Critical Update
I was reading the Federal Register about the FDA's efforts to align medical device regulations with ISO 13485. One particular change caught my eye, especially considering my background. They're planning to remove the definitions for design validation and process validation. Later in the document, it's mentioned that although these definitions are absent, other terms should suffice. See the response to Comment 29.
Back when I conducted training sessions on validation topics for my previous employer, we dedicated a lot of time to differentiating between design validation and process validation. This emphasis is crucial because while there's a clear focus on the product and how regulations affect it, the regulations applicable to the manufacturing process itself might not be as obvious.
These definitions were proposed in February 2022 but didn't make it into the final rule two years later. If this distinction isn't clear to FDA-regulated manufacturers, they could risk failing to meet the manufacturing process requirements due to a misunderstanding that it's separate from the product.
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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.
