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AgVetLink December 2002

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Dual approval of manufacturing GMP

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 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 pharmaceutical 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 pharmaceuticals 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.

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.

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.

ACVM Group opportunity

The ACVM technical team is seeking a part-time veterinarian to assist with work in the veterinary medicines area. Hours are flexible: part-time 5 days a week through to 8 hours a day for up to three days a week. The person we are looking for must be Wellington-based to work closely with Neil Kennington and Jennie Yee. The work will involve undertaking class determinations and assisting in all parts of the regulatory assessment process. This would be a great opportunity for someone getting back into the workforce, especially if you are planning to set up a consultancy business in the future.

A job description is available from:

Gill Wilson 
(email gill.wilson@nzfsa.govt.nz or phone 04 463 2539) or 
Jodie Trubshoe 
(email jodie.trubshoe@nzfsa.govt.nz or phone 04 463 2540).