Audits of overseas manufacturing sites by APVMA-authorised auditors

Where recognised evidence of an overseas manufacturing site's GMP compliance is not available, an overseas manufacturer may choose to undergo an audit by an APVMA-authorized auditor to provide evidence of compliance with the to the Manufacturing Principles and the Australian Good Manufacturing Practice (GMP) Code for the purpose of registering a product to be imported into Australia.

Overseas manufacturing sites may be required to undergo an audit by an APVMA-authorised auditor in situations that include, but are not limited to, the following:

  • when the local regulatory authority of the country where the manufacturer’s site is located is not in a country that has a GMP scheme that is recognised by the APVMA as being equivalent to the Australian Manufacturing Principles and GMP Code
  • where the evidence and information relating to the standards of manufacturing or level of compliance with this standard is insufficient for the APVMA to determine whether the site can meet the prescribed condition of a registration which require a manufacturing site outside of Australia to comply with a standard of manufacture comparable to the Manufacturing Principles and the GMP Code
  • when an overseas manufacturing site is located in a country with a local regulatory authority recognised by the APVMA but the manufacturing site has not been subject to a recent inspection that covers the scope of the GMP Code and Manufacturing Principles or
  • when the overseas manufacturing site is located in a country with a local regulatory authority recognised by the APVMA and although an inspection has been recently undertaken by the regulatory agency recognised by the APVMA, the certificate of inspection does not cover the product type or steps of manufacture.

While the purpose of these audits is to confirm the GMP compliance of the facility, the scope of overseas audits is often limited to the specific product or group of products to be imported into Australia by a particular registration holder.

Overseas audits conducted by APVMA-authorised auditors are to be arranged and paid for by the owner of the audit. The owner of the audit may be the manufacturing facility, the product registration applicant or the product registration holder.

Further information about how an audit is arranged and conducted is available in a separate guideline on arranging and undergoing an audit.

Following satisfactory closure of the audit, the APVMA will issues a letter of recognition for the manufacturing site for a specified period (up to a maximum of three years) to audit owner.

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