Seeking stakeholder input into policy on the scheduling and management of APVMA GMP audits

Submissions are invited from interested stakeholders on the development of policy on the scheduling and management of APVMA GMP audits.

Background

The auditing of APVMA-licensed manufacturing facilities can be described as enforced self-regulation, where the onus is on the manufacturer to have an effective quality management system that maintains product quality.The role of the regulator is to periodically assess whether the manufacturer’s quality assurance system systems is operating effectively and (in most cases) to provide company management with a compliance report that is used to strengthen areas of weakness.The legislation places responsibility for maintaining control of manufacturing facilities on the nominees for Production and Quality [see Agricultural and Veterinary Chemicals Code Regulations 1995, s 61 (6)].

Discussion paper

We have developed a discussion paper which describes a proposal to change the way the APVMA schedules and closes GMP audits.

The discussion paper considers:

• introducing a transparent risk-based methodology for assigning audit intervals,
• progressively increasing the maximum audit intervals to make the benefits of ‘day-to-day’ GMP compliance more apparent,
• assigning a Non-Conformance Score and audit rating that reflects the outcome of the audit,
• allowing ‘trusted’ manufacturers with satisfactory compliance records to close audits on the basis of an approved plan.

The proposed changes to the management of audits are designed to encourage GMP compliance through more transparent processes, as well as provide benefits for ‘earned autonomy’.The objectives are to reduce compliance costs for compliant manufacturers and drive an industry-wide change in attitude and behaviours from ‘just enough; to ‘proactive compliance’.From an APVMA perspective, the benefits include more efficient and effective monitoring activities, targeted towards non-compliance.

Consultation information

• The APVMA is seeking feedback in relation to the discussion paper to ensure the proposed guidance provides clear information to assist manufacturers and auditors.
• The APVMA invites comments on the discussion paper. In preparing your submissions you may wish to consider the following questions:
• Do you have any comments on the proposed approach to the management and scheduling of audits?
• Do you consider that the titles of audit ratings (Audit Level 1, 2, 3 and 4) should be more descriptive , reflecting the extent to which the audit demonstrates compliance with the Manufacturing Principles?
• Do you consider that the audit intervals should be based on the audit rating rather than the NC Score? The impact of this change would be to assign intervals of 12, 18, 24 and 30 months aligned with each audit level, rather than an incremental change aligned with the NC Score.
• Do you consider that there will be any unintended consequences of the proposed approach?
• Do you have any suggestions for improving the proposed approach?
• What further support, if any, should be provided to manufacturers or auditors to ensure that the changes are implemented effectively?
• Do you consider that a transitional period is necessary for implementation of the proposal?

The consultation period is open until close of business on Friday 9 October 2015. All submissions will be published unless you state in your submission that you do not want the submission to be published.

Following consideration of comments the policy on audit scheduling will be finalised, published on the APVMVA website and implemented before 1 January 2016.

Please email your submissions to mls@apvma.gov.au

Hardcopy submissions may be posted to:

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