Best Practices for Retesting and Reconfirmation in OOS Investigations
Out-of-Specification (OOS) results in stability testing demand a thorough, documented response. One of the most critical and closely regulated aspects is the decision to retest and reconfirm the results. Improper handling can lead to accusations of “testing into compliance”, regulatory warnings, or even batch recalls. Regulatory authorities like the CDSCO, USFDA, and EMA mandate specific…
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