8.0 - Laboratory Operations identification tests You must have all records

You must have all records required  readily available during the retention period for inspection and copying by FDA when requested

and under pressure as needed

or holding of a drug product shall have education

Thereafter they must be stored under quarantine until they have been tested or examined

Non-pharmacopeial

8.0 - Laboratory Operations identification tests You must have all recordsYou must establish, follow and maintain written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met. You must verify that the laboratory examination and testing methodologies are appropriate for their intended use