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

equipment and production and process controls

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

You must provide hand-washing facilities that are designed to ensure that an employee's hands are not a source of contamination of components

and composition of the finished batch

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

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