10.4 - Laboratory OOS Investigation & Form batch record equipment and production and process

equipment and production and process controls

and drug products designed to ensure that each lot number conforms to appropriate standards of identity

in-process materials

Any surfaces that contact components

Water that is used in a manner such that the water may become a component of the dietary supplement

10.4 - Laboratory OOS Investigation & Form batch record equipment and production and processIf 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