This consultation closed on 22 August 2024
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is proposing to update the Good Manufacturing Practice (GMP) Audit Procedure.
Background
In Australia, manufacturers of veterinary chemical products must be appropriately licensed by the APVMA. This requirement applies to anyone in Australia involved in any step of manufacture of a veterinary chemical product, unless specifically exempt.
The APVMA administers the Manufacturers’ Licensing Scheme, and the ongoing maintenance of these licenses.
Licensing and audit process
As part of the licence application approval or variation process, if an audit is required, the manufacturer must engage an APVMA–authorised GMP auditor to inspect the premises, equipment, processes, and facilities proposed to be used for the manufacture of a veterinary chemical product. To maintain a licence and confirm ongoing compliance, the licence holder must arrange periodic re-audits as required by the APVMA.
The GMP Audit Procedure document provides detailed instructions on how routine (full or partial) GMP audits of premises are to be planned, conducted, and reported to the APVMA. It covers the procedure to be followed by APVMA–authorised GMP auditors when auditing an Australian veterinary chemical manufacturing facility for compliance with the Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination 2014 (Manufacturing Principles); the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products, 2007 (and relevant annexes—GMP Code); Part 8 of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code); and Part 7 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations).
Updated GMP Audit Procedure
The APVMA, in consultation with APVMA–authorised auditors and Industry Liaison Consultative Forum (ILCF), has now updated the GMP Audit Procedure to address the technical requirements and deficiencies in the current GMP Audit Procedure (published in March 2016).
Making a submission
Submissions in relation to the updated GMP Audit Procedure are invited and must be received by the APVMA by close of business 22 August 2024.
Submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (see public consultation coversheet). Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published. Note that all APVMA documents are subject to access under provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or post to:
Manufacturing Quality and Licensing Team
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2300
Email: enquiries@apvma.gov.au
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