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AgVetLink April 2003

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Collaboration with UK Veterinary Medicines Directorate

Dr Jason Todd, Manager Immunological Inspections, Veterinary Medicines Directorate (VMD), UK, visited New Zealand to conduct regular quality assurance/quality control (QA/QC) inspections at four manufacturing sites in Upper Hutt, Palmerston North, Dunedin and Auckland between 3 March and 13 March 2003. These inspections were carried out jointly with Trish Whitaker, a GMP Inspector with AgriQuality Ltd, under contract to the ACVM Group.

QA/QC inspections are regular reviews of the quality systems of manufacturers of veterinary vaccines that are sold on the UK market. (The inspections are programmed to be carried out annually but slippage can occur when overseas manufacturers are involved.) QA/QC inspections comprise the programme that has been introduced by the UK to enable the release of each batch of veterinary vaccine onto the market by the regulatory authority. Other European regulatory authorities enable batch release of veterinary vaccines through sampling and testing provisions in the European Directives.

This process for the release of each batch of veterinary vaccine onto the market by a regulatory authority is called 'official batch release'. Official batch release is not covered under the Mutual Recognition Agreement (MRA) made with the European Community for conformity assessment of GMP. Therefore, while the visits of GMP inspectors from Europe to approve New Zealand sites for supply to Europe under the MRA have now stopped, inspectors from the VMD would still need to visit annually to enable batch release of vaccines to the UK market.

Prior to the visit, the ACVM Group and the VMD had reached agreement in principle that it would be possible for New Zealand GMP inspectors to perform QA/QC inspections of veterinary vaccine manufacturers' quality systems on behalf of the VMD after an appropriate transitional period for mutual confidence of both regulators. It was agreed that the 2003 cycle of inspections would be carried out jointly and collaboratively by both regulatory authorities; single inspection reports combining the comments of both inspectors would be provided after the inspections.

It was also agreed that the next cycle of inspections due in March 2004 would be carried out by the New Zealand inspector and observed by the VMD inspector. Successful completion of this programme would form the basis of a technical agreement between the VMD and the ACVM Group for the conduct of future QA/QC inspections by the ACVM Group on behalf of the VMD.

The visit therefore had two main purposes:

• to enable the VMD to conduct its routine QA/QC inspections for batch release, and
• to enable the development of a harmonised approach to QA/QC inspections by both regulatory authorities for the development of the technical agreement.

The opportunity was also taken to keep up to date with European trends in GMP.

A good working relationship developed between the UK and New Zealand inspectors, with both playing full and equal parts in the inspections carried out. The UK inspector was pleased with the process and was satisfied that we are on track to complete the transition.

Trial location condition for Provisional Registrations and Research Approvals

The current condition that is imposed on substances subject to a Provisional Registration or Research Approval where the trial site is undecided at the time of application is: "The location of any trial sites not identified in the site and systems in the application must be notified to the ACVM Group as soon as they are known and before the expiry date shown on the certificate".

A review of this wording has revealed a potential problem with regard to tracking and tracing of any incidents relating to such a trial. Knowledge of trial location forms part of the 'track and trace' system to ensure that the whereabouts of animals and plants treated with the test substance is known from the time of treatment until the period of regulatory interest has elapsed. To require this information only prior to the expiry of the certificate, which could conceivably be several months following treatment or application of the substance, is not sound risk management and does not fulfil the intended purpose.

To rectify this, the condition has been changed to read: " The location of any trial sites not identified in the site and systems in the application must be notified to the ACVM Group as soon as they are known".

Applicants should be aware that where this condition applies to a Provisional Registration or Research Approval issued to them by the ACVM Group, it is their responsibility to fulfil this obligation. Failure to comply is likely to result in future applications involving undecided trial locations being declined until they are known.