Overseas manufacturers of veterinary chemical products supplied in Australia can arrange for an Australian Pesticides and Veterinary Medicines Authority- (APVMA) authorised auditor to inspect their site of manufacture.
This option is often undertaken when acceptable Good Manufacturing Practice (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 6 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 6 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.
English translation
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.
Evidence of compliance with GMP
The goal of an audit (as outlined in this advice) is to provide sufficient evidence for the APVMA to assess whether the legislative requirements in relation to GMP have been satisfied. Audits should still be conducted according to the APVMA Good Manufacturing Practice (GMP) Audit Procedure.
Audit types
In-person audits remain the preferred option, when it is safe to do so. Otherwise, manufacturers should contact their auditor to discuss remote or hybrid options. During the consideration of what audit option will work best, holders, manufacturers and auditors may wish to refer to guidance documents on remote audits, for example, from the International Organisation for Standardisation and the Therapeutic Goods Administration.
Audit types, including remote and hybrid audits, are considered below.
In-person audits
In-person or face-to-face audits are the traditional onsite audit format that has been used by APVMA auditors, requiring the physical presence of an auditor on-site at a manufacturing facility and assistance by staff of the manufacturing facility in order to conduct the audit.
Remote audits
Remote audits are audits conducted from a distance. This format might be restricted to a desk audit of the GMP system, including evidentiary documents and records, standard operating procedures, and other relevant documents provided to the auditor. Remote audits might be facilitated by real-time communication with an auditee, including video and audio media and sharing of documentation online, and potentially real-time video of a tour of a facility.
Hybrid audit
A hybrid audit is any combination of in-person and remote components of an audit. The complete audit should be finalised as soon as practicable, but the face-to-face component should be completed only when it is considered safe to do so.