AUDITS MAY BE CONDUCTED FOR A VARIETY OF REASONS
As part of the Manufacturing Authorization Holder evaluation to support a QP declaration of compliance to ICH Q7 for the API used as a Starting Material in the manufacture of Human or Veterinary Medicinal Products.
As part of Supplier Qualification, a Pre-approval audit may be necessary "Start up’ audits would review the adequacy of new facilities and/or manufacturing processes prior to full scale production.
As part of a periodic supplier evaluation, a ‘follow up’ audit would be scheduled to monitor and ensure an adequate level of compliance is being maintained.
A ‘for cause’ audit may be performed to investigate a specific quality failure or process deviation and/or to prepare for a regulatory inspection