Laboratory tests are performed on active pharmaceutical ingredients, excipients and other components, in-process materials, and finished drug products. The investigation of out-of-specification (OOS) results is an important part of the work undertaken in QC-laboratories and continues to be a hot topic in authority inspections. The incorrect handling and investigation of OOS results are still frequently cited in FDA Warning Letters.

Unconfirmed OOS results (= lab errors) require a full and often timeconsuming OOS investigation with a predefined procedure to find the root cause and to define CAPAs.

Against this background, it is essential to thoroughly investigate unconfirmed OOS results and make every effort to prevent the recurrence.

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