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AgVetLink July 2003 - Special Issue for Registrants

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Dual approval – GMP inspections

At its meeting on 21 November, AVMAC endorsed an ACVM Group proposal to accept inspections for good manufacturing practice (GMP) compliance carried out by Medsafe pharmaceutical inspectors for the purpose of issuing a NZFSA Certificate of GMP Compliance.

Inspections

Inspections of manufacturers of registered veterinary medicines are carried out at regular intervals for the assessment of compliance with the ACVM standard and guidelines, where relevant, for GMP. We have learned from the routine inspections carried out that a small number of manufacturers are involved with the production of veterinary and human pharmaceutical products and are therefore inspected under both the ACVM and Medsafe inspection programmes.

We believe that these duplicate inspections comprise excessive regulatory control for a number of reasons:

• Veterinary and human pharma-ceutical manufacturing activities associated with specific types of products are generally very similar.
• The scope, outcomes and procedures for both types of inspection are similar.
• Both inspection groups are applying the same standard for GMP to the assessment.
• Both inspection groups operate under the same mutual recognition agreement for GMP assessment with the European Community.
• Inspections of manufacturers of human and veterinary pharma-ceuticals are often carried out by the same inspectors in other regulatory systems such as the EC.
• The ACVM Group has contracted to Medsafe for specific technical expertise for GMP inspection in the past and may wish to do so in the future.

Dual inspection process

The dual inspection process would work as follows. The inspection cycle time for a combined veterinary and human GMP inspection would remain the same, that is every two years. Prior to the Medsafe inspection all parties would agree that the particular inspection would be a dual one. The ACVM Group would advise Medsafe of any specific issues brought to notice since the last inspection that should be addressed.

The Medsafe inspection would include an additional time component when veterinary medicines (or a sample of them if a significant number are being manufactured) will form the focus of the inspection. The ACVM Group will then provide an ACVM GMP Certificate on receipt and review of the Medsafe inspection report. The cost of the additional time component payable to Medsafe for the veterinary medicine component of the inspection will be recovered from the manufacturer.

Benefits

We believe there are significant benefits for the manufacturers and for the regulators from this proposal. The total inspection cost to the manufacturer will reduce because only one slightly longer inspection instead of two separate inspections will be cost recovered.

The collaboration on inspections will strengthen the technical link between ACVM Group and Medsafe on standards and processes for inspections and will provide a link into the development of the trans-Tasman single pharmaceutical agency.

Finally, only a few people with the training and experience required to conduct pharmaceutical inspections are available. A formal collaboration will make best use of scarce resources and will make it easier to call on alternative technical expertise if required in the future.