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

There should be adequate suitable storage space for samples and records

to ensure the quality

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

and composition of the finished batch

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 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