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AgVetLink June 2003

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Good Manufacturing Practice seminar

The ACVM Group has been advised that a GMP seminar is being organised by the International Society of Pharmaceutical Engineers (ISPE) on 26 or 27 June. The seminar will be presented by Joe Phillips*, a former director of the Food and Drug Administration (FDA).

The proposed agenda for the seminar (about four hours) is:

• FDA’s new risk-based GMP
• FDA quality systems audit approach
• Trends in inspectional observations
• Questions and answers.

The cost is expected to be relatively modest; the venue and final date are to be confirmed. We believe this will be a single rare opportunity to workshop GMP topics with an acknowledged expert. If you wish to receive the seminar details and a registration brochure, please contact Maurice Parlane (email: info@newwayz.co.nz or phone: 09 419 8029).

* Joseph X Phillips, a Bachelor of Science graduate of St Joseph’s University, is Vice President for Pharmaceutical Services at Quintiles Consulting, Rockville, Maryland. Before joining the private sector, he spent 44 years with the FDA. He served as Deputy Regional Director for the Central Region for the last ten years. He has been a frequent lecturer, both domestically and internationally, at ISPE events. He was one of the FDA’s principal negotiators for the development of the Mutual Recognition Agreement (MRA) with the European Union and was the FDA’s Lead to the International Cooperation on Harmonisation (ICH) Expert Working Group (Q7A) in developing the API GMP Guidance. While at the FDA he was instrumental in forming the partnership between ISPE and FDA for the development of the Baseline® Pharmaceutical Engineering Guide series and the scale-up and post-approval changes (SUPAC) ‘Similar Equipment’ Addendum. He serves on the ISPE Technical Documents Steering Committee, the Training Committee, and others. He has received ISPE’s Richard B Purdy Distinguished Achievement Award, and three Vice President Al Gore’s Hammer Awards for reinventing government.

Lime sulfur products

There has been some confusion over the expression of the active ingredient and its concentration for lime-sulfur based agricultural compounds. The registrants of such products were asked for their views on the matter, and the general consensus was that the following statement should be used:

X g/litre sulfur as calcium polysulfide in the form of a soluble concentrate.

Where X is the amount of sulfur in calcium polysulfide. For example, if the formulation contained approximately 295g/litre calcium polysulfide, this would generally equate to 190 g/litre sulfur content. This amendment can be made when registrants next reprint affected labels.

Conference of Residue Chemists

The 19 th Conference of Residue Chemists (19CRC) is to be held at the Novotel Hotel, Brisbane, from 16 - 18 September 2003.

The conference is designed to provide both a formal transfer of knowledge and an opportunity to meet and socialise with other residue chemists, researchers and government regulators from throughout Australia and New Zealand. It is expected to attract approximately 140 delegates from Australia, New Zealand and the Asia-Pacific Region.

Dr Bob Epstein, Deputy Administrator of the USDA’s Agricultural Marketing Services (AMS) Science and Technology programmes, has been invited as guest speaker. The conference has no specific theme but will cover a wide range of topics including:

• reports on environmental investigations, monitoring and research
• residues in foods from use of pesticides and other chemicals
• laboratory accreditation, quality control and quality assurance
• developments in method-ology and techniques
• recent advances in instru-mentation and equipment
• regulatory issues: national and international perspec-tive.

For more information contact:
The Secretariat 
Phone: +61 7-33682644 
Fax: +61 7-33693731 
Email: jon@ccm.com.au