How to Calculate and Interpret OOS (Out-of-Specification) Results: A Step-by-Step Guide
Encountering an Out-of-Specification (OOS) result is a high-pressure event in any pharmaceutical quality control laboratory. It signals that a product batch may not meet its predefined quality standards, potentially impacting patient safety and triggering regulatory scrutiny. A structured, compliant investigation is not just a best practice—it’s a regulatory requirement. This step-by-step guide will walk you through … Read more