Arranging and undergoing an audit

This page contains information about arranging and participating in an audit for GMP compliance. General information about audits by APVMA-authorised auditors is in GMP audit procedure.

How an audit is conducted

At the conclusion of the audit of an Australian manufacturing site, the auditor provides an audit report to the manufacturing facility. Audit reports for overseas sites are provided either to the manufacturing site or the registration holder, whoever commissioned the audit.

The manufacturer should review the audit report and develop a plan to address any non-conformances identified in the audit.

The original report should be signed by the manufacturer’s representative and sent to the APVMA along with a completed Response to GMP Audit Report form within 25 working days of the audit being completed. The form also seeks feedback from the manufacturer about the conduct of the audit.

Unofficial audits by GMP consultants

Manufacturers may engage APVMA-authorised GMP auditors, or any other suitably qualified consultants, to audit their plant at any time to:

  • assess the current level of compliance
  • advise on and assist in meeting requirements of the GMP Code (or equivalent).
However, you cannot use the report of a consulting audit as evidence of GMP compliance for licensing purposes. Audits for licensing purposes can only be carried out by APVMA-authorised GMP auditors, and an auditor cannot perform this task if they have been engaged by the manufacturer on GMP-related consulting matters (other than for licensing or auditing purposes) in the previous two years.

Non-conformances

If non-conformances are identified during the audit, the manufacturer should submit evidence of the corrective actions taken to address them to the auditor within the agreed timeframe. If the auditor considers it appropriate, they may also conduct a verification audit of the site. Once the auditor has assessed the corrective actions as satisfactorily addressing the nonconformances, they will advise us. We will assess this information and provide advice to the appropriate party.

Selecting and contracting an auditor

If the APVMA require you to have an audit by an APVMA-authorised auditor, select an auditor from the APVMA-authorised GMP auditors list and contact them. Obtain a quote and arrange for the audit to be conducted at a time suitable to both parties. After booking the audit:

Audit charges vary depending on the duration of the audit, the complexity of the manufacturing premises and category of manufacture, and the travel required. The auditor, not the APVMA, determines the audit charges.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.