Audits

Audits are used by the APVMA to confirm that manufacturing facilities of veterinary chemical products comply with the APVMA’s Manufacturing Principles and the Australian Code of GMP for Veterinary Chemical Products. Audits are conducted of both Australian manufacturing facilities and overseas manufacturing facilities.

Audits of Australian manufacturers occur prior to the issue of a licence to manufacture veterinary chemical products and also on an on-going basis once a licence has been issued to confirm continued compliance.

Audits of overseas manufacturers occur when there is no satisfactory evidence of GMP compliance available.  Audits of overseas manufacturers are generally arranged by the product registrant or their representative. These audits are conducted by APVMA-authorised auditors and generally focus on specific products or a small range of products specific to the registrant who has arranged the audit. The APVMA will only use the information obtained during the audit for the product registrant or owner of the overseas audit.

Arranging and undergoing an audit

Know when and why you need to arrange an audit for your manufacturing site.

Audit ratings and scores

The APVMA audit review and closure process.

Audits of Australian veterinary chemical product manufacturing sites

Australian manufacturers and the audit cycle—why you're required to undergo regular audits.

Audits of overseas manufacturing sites by APVMA-authorised auditors

The purpose of audits—and how to schedule one—for overseas manufacturers.

Audit closure

The audit closure process and what to do after the transitional period.

The GMP audit cycle

Licensed veterinary chemical manufacturing facilities are audited under what can be described as ‘enforced self-regulation’.

Risk-based scheduling of GMP audits

How audits of veterinary manufacturing sites are scheduled.

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