Failure Investigation

In the event of an out-of-specification (OOS) result from dissolution testing, a detailed review of the samples, data and equipment should take place.

A laboratory investigation should be well documented and followed by retesting according to standard operating procedures and a corrective action to avoid the problem in the future.

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Click on the check boxes below to show a list of items to evaluate during the laboratory investigation of dissolution data.

Check calculations

Click on the check boxes below to show the proper documentation requirements of a thorough laboratory investigation.

Description of the failure with a full data summary should be well
documented

Failure Investigation

A supervisor should conduct a rudimentary investigation between each sample test to ensure that the calculations were correct (eg. the sample preparation should be reviewed, the standard preparation checked and the spectrophotometer results evaluated to ensure that there were no obstructions in the cell during reading. It is for this reason that all samples are saved and not discarded after testing).

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Investigation is also used to highlight any problems that might have occurred in the dissolution test (eg. there might be a calculation error in test 1 which would cause errors in test 2 calculations and would not otherwise be discovered). It is best to perform each investigation early to verify each step.

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