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AgVetLink June 2004: Page 3

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MANUFACTURING MATTERS

Points of interest to manufacturers of veterinary medicines

GMP Inspectors workshop

A GMP Inspectors workshop was held at the end of April in Auckland:

• to review the inspection programme for the year;

• to discuss any particular GMP issues that inspectors had encountered; and

• to consider the process for approval of traders of PAR veterinary medicines when that programme is introduced.

Inspectors noted that not all manufacturing sites visited had complete and current site master files even though this is a requirement under section 2.4.4 of the ACVM Standard for Good Manufacturing Practice. Guidelines for the preparation of a comprehensive site master file can be obtained from Brian Pidford ( brian.pidford@nzfsa.govt.nz ).

If you have a small manufacturing operation, it is appropriate that you keep the form ‘Application for Authorisation to Manufacture Agricultural Compounds and Veterinary Medicines’ up to date, and are able to provide it to the Inspector or the ACVM Group when requested before an inspection takes place. This form contains the basic minimum information that could be considered acceptable as a site master file for a small or uncomplicated manufacturing operation.

Packing and labelling, and the security of storage and reconciliation of these product specific printed items were also areas of mixed performance by manufacturers. Inspectors will continue to look carefully at these processes for deficiencies.

Inspectors were briefed on the importance of the biosecurity system in maintaining New Zealand’s record as an ideal place for manufacture because of its freedom from critical pathogens. Manufacturers are reminded that a biosecurity clearance is mandatory for all materials of animal origin that have been imported for the manufacture of a veterinary medicine. Inspectors will be checking in future for the presence of materials of animal origin, especially those derived from ruminant animals, and the relevant biosecurity clearances.

APVMA

Australian Pesticides and Veterinary Medicines Authority

The APVMA has agreed to work with the ACVM Group on the mutual acceptance of regulatory assessments in the area of animal welfare for companion animal products. It is likely that this will be done as part of the Registration Management Committee work programme, post July 2004.

During a recent visit to Australia to attend the Registration Liaison Committee meeting (see page 5), ACVM Group staff took the opportunity to progress discussions on cooperation on investigations and compliance activity. There is no firm progress on the draft Memorandum of Understanding in this area yet.

The ACVM Group has collaborated for many years with the APVMA on informally recognising the competence of each other’s manufacturers of veterinary medicines. This collaboration has included regular visits to maintain contact and to understand the Australian regulatory programmes. A Memorandum of Understanding is being developed with the APVMA to formalise the arrangements for accepting each other’s manufacturing approvals.

APVMA visitor

Kathy Winterton, who administers the Manufacturers GMP Programme in Australia, visited New Zealand for two weeks in April to familiarise herself with the GMP approval process in New Zealand as part of the ongoing informal mutual recognition agreement between New Zealand and Australia. During her visit Kathy observed an ACVM Group GMP inspection and visited three other manufacturers who currently export to Australia. She also attended the GMP Inspectors workshop, and briefed the ACVM Group on the APVMA GMP Programme.

 

Transfer of substances under the HSNO Act

In transferring substances to the main framework of the Hazardous Substances and New Organisms (HSNO) Act 1996, there is a legal requirement to consult on the classification and controls that will apply following transfer. While proposed classifications will be checked, it is advised that registrants are aware of the controls being applied to their specific products and ensure that these are appropriate. The Hazardous Substances (Classification) Regulations 2001 assign a classification to substances with hazardous properties and can be used for reference.