This content is current only at the time of printing. This document was printed on 18 September 2020. A current copy is located at http://www.xlg888.com/node/19646
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APVMA audits of overseas manufacturers
Overseas manufacturers of veterinary chemical products supplied in Australia can arrange for an APVMA-authorised auditor to inspect their site of manufacture.
This option is often undertaken when acceptable GMP evidence is not available. This can include situations where the manufacturer is in a country where the APVMA does not recognise—or have an agreement or understanding with—their government’s regulator for their particular product.
APVMA audits of overseas manufacturers are conducted similarly to audits undertaken in Australia. The main difference is the audit usually only covers products to be imported to Australia, rather than the manufacturer’s full range of veterinary chemical products. The auditor assesses the manufacturer to determine compliance with the Australian GMP Code for veterinary chemical products.
The overseas pre-audit notification and information form should be submitted to the APVMA at least 4 weeks before the audit is conducted.
Overseas manufacturers arranging an audit of their site with an APVMA-authorised auditor should notify the APVMA beforehand. The Overseas Pre-audit Notification and Information form?should be submitted to the APVMA at least four weeks before the audit is conducted.
If the overseas site demonstrates compliance with the Manufacturing Principles and the GMP Code, the APVMA will issue a letter to confirm the site’s GMP compliance. These letters are issued for the purpose of registering veterinary chemical products in Australia or for ensuring continued evidence of GMP compliance is held by the product holder.
Overseas manufacturers must ensure English translations of all documents are available for review by the auditor during the audit. Where the auditor is unable to review any documentation due to an English translation not being available a further audit or desk audit may be required to assess any information which was not available for review earlier.? Any documentation submitted to the APVMA in relation to an audit, given at any point in time, must also be in English. English translations will be requested for any documents provided in a language other than English.