International GMP harmonisation guide set to assist business and governments
The International Alliance of Dietary/Food Supplement Associations (IADSA)’s David Pineda said the guide took in GMP set-ups in all parts of the world, especially well-established regimes such as those in the US, Japan, the European Union and Australia.
“The guide is not reinventing the wheel but is intended as a tool for both governments and industry on best practices to carry out food supplements manufacture,” Pineda said.
“Our working group has worked on this and it was encouraging to see so many GMP regulations have the same provisions, and look at the same processes. So a focus of the guide is ensuring common terminology for these processes.”
Pineda said the guide would prove useful in regions that were in the throes of developing their own GMP rules such South America, Africa and the 10-country strong Association of South East Asian Nations (ASEAN).
Guide detail
IADSA’s ‘Global Guide to Good Manufacturing Practice for Supplements’ was agreed at IADSA’s annual meeting in California last week.
It covers covers quality management, premises and equipment, personnel and training, product and process development, manufacture, storage, transport and distribution.
Other subjects include recovery or re-working of materials, documentation, self-inspections, sub-contracting operations, laboratory testing, complaints procedures, product recall and emergency procedures.
“This guide has been developed for use by every supplement manufacturer, from the smallest independent business to the largest corporation, within the poorest country to the wealthiest,” said IADSA Chairman Peter Zambetti in a statement.
“Considerable thought has been given to the terminology used throughout the guide, due to the contrasting legislative positioning of supplements in different parts of the world and the global variations in interpretation of specific words and phrases.”
Sam Jennings, coordinator of IADSA’s GMP Working Group added: “This is the culmination of many months of work and discussion over the past year by a number of leading experts in this field. We have had high level input from the ASEAN region, Europe, Japan and the USA. This is invaluable because manufacturers and distributors of supplements should not only comply with all relevant national legislation in their home country, but also that of any countries to which they export their products.”
ASEAN is comprised of Malaysia, Indonesia, Thailand, Vietnam, the Philippines, Laos, Brunai Darussalam, Cambodia, Myanmar and Singapore. Some of those nations have GMP regulations in place, but there is an ASEAN objective to harmonise GMP and other food regulations by 2015.