The Case of the Failed Batch
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The Case of the Failed Batch
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This episode talks about the FDA-mandated guidance document for managing out-of-specification (OOS) results within the pharmaceutical industry. The guidance emphasizes a rigorous two-phase investigation to determine if a failure stems from a laboratory error or a deeper manufacturing flaw. Phase I focuses on the analyst’s immediate assessment of technical accuracy, while Phase II involves a full-scale review of production processes by the quality unit. Crucially, the sources warn against "testing into compliance," noting that companies cannot simply retest a sample until it passes without a scientific root cause for the initial failure. Ultimately, the documentation underscores that maintaining scientific integrity and protecting patient safety must take precedence over the desire to release a product batch.