This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/140
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Overseas GMP documentation
Registrants of veterinary chemical products where one or more steps of manufacture are conducted overseas need to provide certain types of documentation as evidence of overseas Good Manufacturing Practice (GMP)?compliance.
Decisions often need to be made on a case-by-case basis due to differences in individual circumstances and the underlying legislation in different countries.
Decisions on the types of evidence the Australian Pesticides and Veterinary Medicines Authority (APVMA) accepts often need to be made on a case-by-case basis due to differences in individual circumstances and the underlying legislation in different countries.
Where equivalence is established, the APVMA can accept overseas certificates of GMP compliance or similar documentation from that country.
1. Quality of overseas documentation
All certificates must be fully legible and complete. If certificates or other documents have accompanying pages, ensure all pages are supplied to the APVMA.
Bilingual certificates are acceptable provided one of the languages is English. If the certificate or other documentation has been issued in a language other than English, a notarised English translation must be provided as well as a notarised copy of the original certificate or other document.
2. Validity of overseas documents
Documents should usually be obtained from a government authority that is recognised by the APVMA.
We do not usually accept documents from non-government inspection bodies as primary evidence of GMP compliance. There must be no qualifying statement on a certificate that renders it invalid – such as a statement that ‘the certificate is issued for the Government of the UK and must not be used for any other purpose’.
Certificates and audit reports are only accepted for 3 years after the date of the last inspection or until the expiry date shown on the certificate (whichever is earlier). Certificates that claim validity for more than 3 years are only accepted for a maximum of 3 years after the last inspection date. A certificate that has an expiry date less than 3 years hence will only be accepted until the stated expiry date.
3. Information to include in the documents
The certificate or audit report must be dated. The document must clearly communicate:
- it has been issued for the manufacture of veterinary chemical products or veterinary medicines
- the manufacturing facility is authorised to manufacture the type of product under consideration
- the facility is regularly inspected for compliance with the relevant GMP Code.
The scope of a certificate or audit report must cover the type of product to which the application relates and the relevant steps of manufacture.
The name and street address of the manufacturer on the certificate must be identical to that shown on the application form for registration.
It is also preferable that the last inspection date be listed on the certificate. If no satisfactory documentary evidence of compliance can be provided, the overseas manufacturing facility will need to be audited by an?APVMA-authorised auditor?for compliance with the Manufacturing Principles and the GMP Code.
4. Audit reports of overseas sites
The APVMA will consider audit reports from an:
- APVMA-authorised GMP auditor from Australia
- auditor from one of the overseas authorities recognised by the APVMA.
In certain circumstances, the APVMA may consider an audit report from an alternative quality assurance certifying body that is internationally recognised. However, manufacturers must seek and attain permission from the APVMA before the audit takes place.
5. Submitting overseas documents to the APVMA
Certificates and other evidence of GMP compliance should be submitted electronically to the APVMA.? However, the APVMA expects that the original certificate or a copy of the original certificate is maintained and provided to the APVMA on request.