This content is current only at the time of printing. This document was printed on 28 March 2017. A current copy is located at http://apvma.gov.au/node/151
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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.
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:
- for an Australian audit, submit a Pre-Audit Notification and Information form to the APVMA
- for an overseas audit, submit a Pre-Audit Notification Form—Overseas Audits.
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.