10.4 - Laboratory OOS Investigation & Form batch record There should be adequate suitable

There should be adequate suitable storage space for samples and records

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

and composition of the finished batch

10.4 - Laboratory OOS Investigation & Form batch record There should be adequate suitableIf 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