What I mean is: what will happen in an audit if the batch codification does not accomplish the requirements?
can you help me with this?
During an audit, when there is a finding, the auditor would first want to know look at your documented procedure and followed by checking with you whether any appropriate justification can be provided for the deviation.
In the case of a minor deviation from the requirement, they would want to know whether any correction has been taken and documented in the form of CAPA. If this has been addressed appropriately, the auditor would likely put it as an observation.
In the case where no corrections are taken, the auditor would require a justification as to why no actions are being taken. A non conformity will be raised in which the auditee would be given a reasonable period of time to perform the corrections.