Case Study: Beyond the Method - Insights from a Vitamin D Product Analysis
In a recent OOS investigation, a client submitted a powdered Vitamin D drink product for routine testing. Initial results were out-of-specification (OOS), and subsequent retests failed to meet the expected criteria. The client was confident the issue stemmed from the laboratory’s method and requested a deeper review.
To troubleshoot, the lab requested the sample raw material used in the product for spike recovery—a control used to verify method accuracy. Interestingly, when the lab used this raw material the spike recoveries met specification. This pointed to a critical insight: the issue wasn’t with the method, but with the client’s actual product.
Further investigation revealed inconsistencies in the client’s formulation and blending process. The active ingredient wasn’t being evenly distributed throughout the powder, leading to variable results. This discovery helped the client reevaluate their manufacturing protocols, including mixing procedures and quality control checkpoints.
Key Takeaway
Sometimes the root cause of an OOS result lies not in the method, but in the product itself. Collaborative troubleshooting can uncover formulation flaws that standard testing alone might miss.
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