This content is current only at the time of printing. This document was printed on 25 February 2017. A current copy is located at http://apvma.gov.au/node/164
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Auditing of Australian veterinary chemical product manufacturing sites
A licence holder who wants to increase the scope of their licence to include additional manufacturing steps may be required to undergo a partial audit to assess whether the site is suitable for and capable of performing the additional operations.
The auditor prepares a report, including their findings on the facility’s compliance with the GMP Code. The report also details any non-conformances found during the audit. It is up to the manufacturer to determine the most appropriate corrective actions. We then determine whether those actions are adequate and have been implemented appropriately.
Based on the audit report (and any other relevant information), the APVMA may:
- issue or continue a licence
- refuse to issue a licence
- defer issuing a licence until we are satisfied that all non-conformances have been corrected
- impose conditions on a licence or
- suspend or cancel an existing licence.
Further information about how an audit is arranged and conducted is available in a separate guideline on arranging and undergoing an audit.
The APVMA also participates in joint, observed and unannounced audits of licensed manufacturing premises to monitor day-to-day compliance with the GMP Code. These audits can also provide useful feedback on the effectiveness of our routine auditing program. Unannounced audits are conducted under the monitoring provisions of the Agvet Code. We usually identify facilities for unannounced audits based on risk, although some may be randomly selected. Risk factors include:
- discrepancies in audit reports
- the extent and seriousness of non-compliance identified in audit reports
- the time since the previous audit of the premises
- the compliance history of the premises
- reports of product recalls or adverse experiences.
APVMA-authorised GMP auditors
The APVMA maintains a list of APVMA-authorised auditors who are available to conduct GMP audits. They are not employed by or contracted to the APVMA, but conduct their audits under contractual agreements between the auditor and the manufacturer. The cost of the audit is borne by the manufacturer.
We authorise GMP auditors on the basis of their knowledge and experience in the production and regulation of veterinary chemicals or pharmaceuticals and their thorough knowledge of the Agvet Code and the Manufacturing Principles.
We have measures in place to ensure that auditors do not have any conflict of interest that could undermine the independence and integrity of the Manufacturers’ Licensing Scheme and that they treat all company information supplied to them as confidential.
Audit scheduling—the GMP audit cycle
Figure 1 outlines the various steps in the GMP audit cycle and the roles of manufacturers, auditors and the APVMA.
Figure 1 The GMP audit cycle
The re-audit interval is set as part of the audit closure process and is based on the compliance risk of the manufacturer. The risk factors we take into account include:
- changes to staff and the scope of a manufacturing licence
- the risks of a quality-control system breakdown occurring, based on the audit history of the manufacturer (number of non-conformances and repeat non-conformances)
- the consequences of such a breakdown, based on the nature and use of the products being manufactured
- the number and nature of recent product recalls and adverse experience reports.
This risk-based approach to audit scheduling is consistent with the practices used by other national and international regulatory agencies. We can modify a re-audit schedule at any time in response to new information presented to us or the introduction of a novel manufacturing system for the premises.
Audit reports from other recognised regulators
We may recognise certification or licensing from the Therapeutic Goods Administration (TGA) or the National Association of Testing Authorities, Australia (NATA) as evidence of compliance with the Manufacturing Principles and GMP Code.
Challenging audit outcomes
We encourage manufacturers to provide feedback to us after each audit. If a manufacturer disagrees with the auditor's approach or findings, they may raise their concerns with us. Depending on the nature of those concerns and the outcome of our investigation, we may set aside an adverse audit finding, provide feedback to the auditors, or both.