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GLP compliance for residue data

from field trials submitted after 1 January 2003

It has recently been noted that there is some confusion with respect to requirements for residue data from field trials to be submitted after 1 January 2003.

At present, the relevant requirements are set out in the following standards and guidelines:

• ACVM Registration Standard for Residue Data;
• Registration Guidelines for Residue Data: Veterinary Medicines;
• Registration Guidelines for Residue Data: Plant Compounds;
• ACVM Research Standard.

It has been brought to our attention, however, that the standards are misleading because of the difference in scope of good laboratory practice (GLP) covering plant compounds and veterinary medicines. Internationally, the specifications for field trials and studies, i.e. good field practices (GFP), are included in GLP. On the other hand, specification for field trials and studies for veterinary medicines are included in a separate standard for good clinical practice. For that reason the ACVM Group would like to confirm the following:

• The above standards and guidelines have been mandatory since July 2000.
• Data for the laboratory component of residue trials submitted after 1 January 2003 must be GLP compliant (i.e. all analytical laboratory trial studies must be carried out by a GLP accredited laboratory).
• Data for the field component of residue trials submitted after 1 January 2003 must comply with the ACVM Research Standard but accreditation to GLP for the purposes of field work is not essential (unless specifically stated). This data should comply with the principles of the field component of GLP (as expressed in the ACVM requirements).

If field trials have been carried out by a GFP accredited person, in its assessment of the subsequent application, the ACVM Group would not require full examination of all trial documentation because audits associated with accreditation would justify the rigour of the submitted trial data. There is no intention, however, to set such a rigorous standard and the ACVM Group will continue to examine the trial documentation to the extent necessary to ensure that the work was carried out to the ACVM Research Standard.

Antibiotic resistance

The ACVM Group advised all licensees of products containing zinc bacitracin and macrolides that their licences must be updated (by 1 May 2002) to include new conditions that manage antibiotic resistance. The details of the review for these products can be found on the ACVM website at http://www.maf.govt.nz/acvm/topics/antibiotic-resistance/index.htm .

The licences for the four top priority antibiotics have already been completed. These involve products that contain:

• avoparcin
• avilamycin
• fluoroquinolones
• virginiamycin.

The Ministry of Health is considering the review report of three other anti-microbial families. This includes the ionophores, flavophospholipols and quinoxalines. The licensing requirements for products containing these three ingredients will be reviewed when the report is finalised.

This will complete the review of all in-feed antibiotics. All those that are significant to antibiotic resistance in humans have been made prescription products, and the licensees have been directed to remove therapeutic use and growth promotion claims from their labels.  Changes will be effective from July 2002 at the latest.