Seeking stakeholder input into the management of the APVMA GMP Code

Consultation period: 
9 September 2019 to 29 November 2019

Background

Submissions are invited from those interested in the revision and management of the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products (the GMP Code), under the Agricultural and Veterinary Chemicals Code (Manufacturing Principles) Determination 2014. This includes the governance of the GMP Code, comments on the risk-based scheduling and management of GMP audits, and suggestions for proposed revisions to the GMP Code.

Consultation information

The role of the regulator in the auditing of APVMA-licensed manufacturing facilities is to periodically assess whether the manufacturer’s quality assurance system is operating effectively and provide the manufacturer with a compliance report to strengthen areas of weakness. The legislation outlines the license conditions for manufacturers of veterinary products (Agricultural and Veterinary Chemicals Code Regulations 1995, r61).

The APVMA is seeking feedback in relation to the GMP Code to ensure the guidance provides clear information to assist manufacturers and auditors in their adherence to the Code, and the identification and resolution of non-compliance.

A number of broad areas to inform discussion about the GMP Code are below, however, submissions may canvas other issues of importance to stakeholders. The consultation considers:

  1. the governance of the GMP Code (eg, the role and composition of the Manufacturing Licensing Scheme-Industry Liaison Committee (MLS-ILC))
  2. comments on the current auditor management process, where manufacturers directly contract external, APVMA-approved auditors
  3. comments from manufacturers on the impact of the risk-based audit interval determination to decrease non-compliance, and to reduce the regulatory burden on compliant sites
  4. the core elements of GMP, outlined in the GMP Code and Annexes
  5. the scope of the GMP Code in the context of international schemes to support the export of products manufactured in Australia. This may include reference to other international schemes, like the Pharmaceutical Inspection Co-operation Scheme (PICS) or FAMI-QS
  6. recommendations so we can ensure adequate consultation on any proposed changes to the GMP Code
  7. the type and frequency of further support, if any, that should be provided to manufacturers or auditors to ensure compliance with the GMP Code.

Making a submission

The consultation period is open until close of business on 29 November 2019.

Note that all submissions received are subject to legislation, including the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes. In providing your submission to the APVMA, you agree to the APVMA publicly disclosing your submission in whole or summary form.

Following consideration of comments received from this consultation, a discussion paper outlining proposed changes to the governance and management of the GMP Code will be published for a subsequent consultation.

Electronic submissions are preferred, and may be sent to:

Manufacturing Quality and Licensing
mls@apvma.gov.au

Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.