Arranging and undergoing an audit

Most veterinary chemical product manufacturers in Australia, as well as and some overseas manufacturers, need to engage an Australian Pesticides and Veterinary Medicines Authority- (APVMA) authorised auditor to inspect their site, equipment and processes.

This is because Australian manufacturers need to provide evidence that they comply with the Manufacturing Principles and the Good Manufacturing Practice (GMP) Code to apply for a licence or retain an existing one.

The APVMA operates an overseas GMP scheme for overseas manufacturers supplying intermediate or finished veterinary chemical products to Australia. Where an overseas manufacturer is unable to provide satisfactory evidence of GMP compliance, it is likely they will need to undergo an audit by an APVMA-authorised auditor in accordance with the GMP audit procedure

1. When to arrange an audit

Manufacturers applying for a licence to manufacture veterinary chemical products in Australia must arrange and undergo an audit as part of the licence application process unless they already hold evidence from a recognised body.

Licensed manufacturers are assigned an audit schedule by the APVMA. This means they need to arrange for an APVMA-authorised auditor to carry out the audit before the next audit due date. The APVMA will notify the manufacturer of the next audit due date, in the audit closure letter for the current audit.

Manufacturers may also request or be required to have a ‘partial’ audit between scheduled dates, meaning only certain aspects of the site or process are inspected. Partial audits are most often requested when the manufacturer is applying to the APVMA to vary their licence to extend its scope.

Overseas manufacturers may need to arrange an audit of their site prior to submitting an application to register a product. Overseas manufacturers audited by the APVMA are then required to organise audits according to the schedule set by the APVMA to ensure ongoing compliance with GMP throughout the life of the product’s registration.

2. Selecting and engaging an auditor

Manufacturers in Australia may only use APVMA-authorised auditors to audit their site for compliance with the Manufacturing Principles and GMP Code.

The APVMA publishes a list of APVMA-authorised auditors. Generally, manufacturers may select their own auditor from the list, however, the APVMA reserves the right to participate in the audit or to reject the manufacturer’s choice and nominate an auditor it considers to be appropriate.

Unless given prior approval by the APVMA, manufacturers must only engage auditors who:

  • do not have a financial interest in them
  • have not previously been in their employ
  • have not provided consultancy services to them in the past 3 years
  • have not conducted more than 2 consecutive, full audits of them.

A declaration confirming the above must be signed by the auditor upon accepting the engagement. This is provided to the APVMA on the confirmation of audit booking form (FM_MQL23).

Manufacturers can contact their selected auditor directly from the list and arrange for the audit to be conducted at a suitable time within the assigned audit schedule. After booking the auditor, the manufacturer is responsible for notifying the APVMA.

Manufacturers in Australia must notify the APVMA via the pre-audit notification and information form (FM_MQL04). Overseas manufacturers need to use the form pre-audit notification – overseas audits (FM_MQL45).

3. Audit duration

The APVMA-authorised auditor and manufacturer must consult with the APVMA when determining the duration of the upcoming GMP audit.

The audit duration will take into consideration the following:

  • Licence categories, steps of manufacture and product dosage forms.
  • Previous GMP audit history.
  • A review of the current product registrations and permits.
  • Any concerns or issues highlighted by the APVMA.
  • Advice from the APVMA-authorised auditor/s.

The delegate will decide what minimum audit duration (in days) is applicable for the manufacturing site. This information will be conveyed to both the APVMA-authorised auditor and the manufacturer.

Unless extenuating circumstances occur, it is expected that both parties will comply with the APVMA directive. Where extenuating circumstances present the manufacturer must apply via email for reconsideration by the delegate of the decision.

4. Audit charges

Audit charges vary depending on the duration of the audit, the complexity of the manufacturing premises, the category of manufacture, the travel required and the APVMA-authorised auditor’s own fee schedule.

APVMA-authorised auditors are not employees of the APVMA, they are independent businesses and consultants. This means the auditor, not the APVMA, determines the audit charges, provides a quote and invoices the manufacturer directly for their services.

The manufacturer is responsible for meeting all costs of the audits. This includes any follow-up work required to close out the audit, such as verification audits or desk reviews.

5. How an audit is conducted

An auditor’s role is to systematically and objectively collect and analyse sufficient relevant evidence to make an assessment of the manufacturer’s compliance with the APVMA’s GMP requirements.

Their main objectives are to:

  • determine the extent of a manufacturer’s compliance with APVMA requirements
  • ensure products are consistently manufactured to the required safety and quality standards
  • identify areas where the quality system needs to be improved.

The auditor must clearly differentiate between identifying non-conformance with the requirements of the Manufacturing Principles and/or the GMP Code.

Although the auditor may discuss various options for improvements and corrective action, it is the responsibility of the manufacturer to determine the most appropriate course of action to address identified non-conformances.

6. After the audit

Once an Australian manufacturing site has undergone an audit, the auditor provides their report to the manufacturing facility. Audit reports for overseas sites are provided to the manufacturing site or registration holder, whoever commissioned the audit.

The manufacturer should review the audit report and develop a plan to address any identified non-conformances.

The original report must be signed by the manufacturer or their representative and sent to the APVMA along with a completed Response to GMP audit report form - Part 1: Manufacturer's Response to Audit Report (FM_MQL26) within 25 working days of the audit being completed. The form also seeks feedback from the manufacturer about the conduct of the audit.

7. Non-conformances

If non-conformances are identified during the audit, the manufacturer must submit certain information to the auditor before the audit can be closed.

The type of information required will be determined based on the outcome of the audit.

8. Audit closure

The APVMA determines when an audit is officially ‘closed out’ and provides manufacturers with written advice accordingly.

Before the APVMA can close an audit, the auditor must provide it with written advice confirming all corrective actions arising from the audit have been completed or that a satisfactory corrective and preventive action (CAPA) plan has been approved.

Audit closure notifications also provide the due date for the next audit, according to each manufacturer’s audit schedule.

9. Unofficial audits by GMP consultants

Manufacturers may engage APVMA-authorised GMP auditors, or any other suitably qualified consultants, to audit their site at any time to:

  • assess the current level of compliance
  • advise on and assist in meeting the requirements of the GMP Code (or equivalent).

Audits for licensing purposes can only be carried out by APVMA-authorised GMP auditors. An auditor cannot perform this task if they have been engaged by the manufacturer on GMP-related consulting matters—other than for licensing or auditing purposes—in the previous three years. This means manufacturers cannot use the report of a consulting audit as evidence of GMP compliance for licensing purposes.

10. Quality assurance under the Manufacturers’ Licensing Scheme

There are a number of ways we maintain a high-quality auditing scheme, one being the way we select our auditors. Auditors are selected based on their experience, qualifications and familiarity with the Manufacturing Principles and the Code of GMP. We also conduct training workshops and joint audits and send APVMA staff to audits as observers.

APVMA staff can conduct unannounced audits of manufacturing facilities to monitor day-to-day compliance with the GMP Code.

These audits can provide useful feedback on the effectiveness of our routine auditing program.

Unannounced audits are conducted under the monitoring provisions of the Agvet Code.

We usually identify facilities for unannounced audits based on risk, although some may be randomly selected. Risk factors include:

  • discrepancies in audit reports
  • the extent and seriousness of non-compliance identified in audit reports
  • the time since the previous audit of the premises
  • the compliance history of the premises
  • reports of product recalls or adverse experiences.

We welcome feedback from manufacturers about audits of their facilities, including any concerns they might have about the auditors. Manufacturers can comment by contacting us directly and/or completing the Response to GMP audit form - Part 2: Manufacturer’s Feedback to APVMA (FM_MQL26).

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