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-authorised auditor in accordance with the GMP audit procedure. They can then provide evidence of compliance with the Manufacturing Principles and the Australian Good Manufacturing Practice (GMP) Code for the purpose of registering a product to be imported into Australia.

Purpose of audits

While the purpose of an audit 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 manufacturing sites may be required to undergo an audit by an APVMA-authorised auditor when:

  • the local regulatory authority of the country where the manufacturer’s site is located does not have a GMP scheme that is recognised by the APVMA
  • 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
    • this may require a manufacturing site outside of Australia to comply with a standard of manufacture comparable to the Manufacturing Principles and the GMP Code
  • 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
  • the overseas manufacturing site had an inspection recently undertaken by the regulatory agency recognised by the APVMA, but the certificate of inspection does not cover the product type or steps of manufacture.

Audit scheduling

Overseas audits conducted by APVMA-authorised auditors are to be arranged and paid for by either 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.

Following satisfactory closure of the audit, the APVMA will issue a letter of recognition for the manufacturing site for a specified period to the audit owner. The period is based on the perceived risk of the manufacturing facility and the products being manufactured.

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