10.4 - Laboratory OOS Investigation & Form batch record Wet chemistry requirements of the

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

equipment and production and process controls

Any surfaces that contact components

in-process materials

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

10.4 - Laboratory OOS Investigation & Form batch record Wet chemistry requirements of 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