This content is current only at the time of printing. This document was printed on 24 March 2017. A current copy is located at http://apvma.gov.au/node/295
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Audits to obtain and vary a licence
As part of the licence application approval process, if an audit is required the manufacturer must engage an APVMA-authorised GMP auditor to inspect the premises, equipment, processes and facilities proposed to be used in the manufacture of a veterinary chemical product.
The auditor prepares a report that includes:
- their findings of the facility’s compliance with the GMP Code and APVMA requirements
- details of any non-conformances found during the audit.
Manufacturers are responsible for determining the most appropriate corrective actions to address any non-conformances arising from an audit. We determine whether these actions are adequate and have been implemented appropriately.
Based on the audit report and any other relevant information the APVMA may:
- issue a licence
- defer issuing a licence until we are satisfied that all non-conformances have been corrected
- refuse to issue a licence.
Before the audit, the applicant must submit a pre-audit notification and information form which provides additional information about the facility as well as notifies us when the audit will be conducted and by which auditor. The audit is to be conducted in line with the GMP audit procedure.
Variation of existing licence
We consider applications to change the scope of a licence on a case-by-case basis. Some variation applications may require an audit; for example, an audit would almost certainly be required to demonstrate capability to manufacture a new product type.
Where a partial audit of a manufacturer is required outside of the normal auditing schedule, a licence variation fee is payable.
An audit would not usually be required when the scope of a licence is being reduced.
In order to maintain a licence and confirm ongoing compliance, the licence holder must arrange periodic re-audits as required by the APVMA.
Assessment of audit reports
Following an audit, the manufacturer must provide the audit report and associated documentation to the APVMA for assessment. In assessing this documentation we consider:
- any non-conformances identified in the audit report
- whether these non-conformances have been rectified following corrective action
- any other matters we consider relevant
- whether the applicant can comply, or in the case of an existing holder is complying, with conditions of the licence.
Once this assessment has been completed the APVMA will determine whether the audit can be officially ‘closed-out’ and provides manufacturers with written advice.