10.4 - Laboratory OOS Investigation & Form batch record You must verify that the

You must verify that the laboratory examination and testing methodologies are appropriate for their intended use

Any surfaces that contact components

or distribution record associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or

Wet chemistry requirements of the Quality Control (QC) Laboratory with respect to written procedures and specifications

10.4 - Laboratory OOS Investigation & Form batch record You must verify that theIf the result of any test or examination fails to meet the established specification or trend, the lot and any other implicated lots must be quarantined and an out of specification (OOS) investigation conducted to determine the validity of the result. That lot may only be retested and released if the investigation clearly determines a laboratory error in the original result