This consultation closed on 22 August 2024
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has finalised updates to 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 GMP Audit Procedure published in March 2016.
Submissions received
The APVMA sought feedback on the proposed update of the Good Manufacturing Practice Audit Procedure, in a consultation that closed on 22 August 2024.
A total of 4 submissions were received. One respondent asked for this submission to remain confidential.
A copy of the published submissions is available on our website.
Consultation outcomes
The APVMA has updated the GMP Audit Procedure taking into consideration the submissions received from public consultation.
The updated GMP audit procedure will be effective from 10 March 2025.