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AgVetLink: Number 52, October 2005

Good Manufacturing Practice update

Inspection programme

The programme of inspection for GMP compliance has been developed for 2005-2006, and the manufacturers involved have been notified. They will be contacted directly by an inspector to schedule the visit.

A workshop of GMP inspectors is being held on 18 October 2005 for training and collaboration. An invited representative from industry has kindly agreed to provide industry input to the proceedings.

TPMA, a new industry organisation

The New Zealand Therapeutic Products Manufacturers Association Inc (TPMA) is an association formed by manufacturers of nutritional and pharmaceutical products “to provide leadership to New Zealand’s therapeutic product manufacturers, to influence the direction of related legislation and to promote education and training in relation to Good Manufacturing Practice”.

Nine organisations came together in 2003 to address the need for training for technical operators and for GMP. The membership is now twenty-five organisations, and more than 60 people attended the Association’s AGM in August 2005.

Two industry qualifications have been registered on the New Zealand Qualifications Authority framework:

• National Certificate in Pharmaceutical and Allied Products Manufacturing, Levels 1 and 2

• National Certificate in Engineering and Technology (Pharmaceuticals and Allied Products), Levels 1 and 2.

Level 3 courses are being developed.

The Association has an operational focus to develop technical training and retention of trained employees, to improve communications and mutual support within the industries, and to develop GMP expertise and improved GMP compliance.

New European Manufacturers Database – EudraGMP

Of interest to manufacturers whose products enter the EC under the mutual recognition agreement (MRA) for GMP, the European Medicines Agency (EMEA) is implementing a new Internet-based database for manufacturers of veterinary medicines, called EudraGMP. The main drivers for this development are to:

• comply with European Directives

• bring all the existing databases of the individual member states into a new centralised database

• facilitate the exchange of information between member states regarding manufacturing authorisations, GMP certificates of sites within member states, GMP certificates of sites in third countries inspected by EC inspectors, negative GMP compliance reports, and GMP inspection schedules

• manage the large number of European manufacturers efficiently (currently the EMEA database holds 800 manufacturers. The new European legislative requirements will increase this to around 20,000, not including manufacturers of active ingredients, in the 25 member states).

New Zealand, as a MRA partner with the EC, has been advised of the development and asked whether we would like to participate with access to the database either on a read only basis, or on a write access basis. As further information is provided, affected manufacturers will be consulted on the extent of participation and on the information that might be required to be made available to the database.