10.4 - Laboratory OOS Investigation & Form batch record in-process materials

in-process materials

and composition of the finished batch

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

There should be adequate suitable storage space for samples and records

equipment and production and process controls

10.4 - Laboratory OOS Investigation & Form batch record in-process materialsIf 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