IADSA Global Guide to Good Manufacturing Practice for Supplements Sam Jennings, IADSA Technical Group March 2011

Why the need for a Global Guide to Good Manufacturing Practice? Regular international issues challenging safety and quality of supplements. Frequent adverse media stories around the world. Supplements often appear in EU Rapid Alert System, with many products or raw materials originating from countries outside the EU. Reports have also occurred in WHO International Food Safety Authorities Network (INFOSAN). All could be prevented by an adequate system of Good Manufacturing Practice (GMP). GMP requested by many governments.

IADSA Global GMP Guide In order to raise the standard of supplement manufacturing, thereby reducing the incidence of safety and quality issues across the globe, the decision was adopted at the IADSA AGM in Istanbul in March 2010 to proceed with a global guide to GMP for supplements.

IADSA Global GMP Guide The working group created comprised of experts from around the globe, with additional members joining through the year. The core members of the group represented: ASEAN European Union Japan United States of America

IADSA Global GMP Guide Remit: To produce a non-prescriptive but comprehensive guidance document covering the essential requirements of GMP for Supplements which will satisfy all regions of the world, bearing in mind that there are considerable variations in the capabilities and financial circumstances of these different regions.

IADSA Global GMP Guide The IADSA Guide is based on a range of the best available reference sources for supplements worldwide, including the US cGMPs for dietary supplements, the EHPM Quality Guide for Food Supplements, etc.

IADSA Global GMP Guide Detailed review of all available national GMP laws/requirements carried out, including food and pharmaceutical guidelines. Found that basic principles of GMP were the same. The documents only differ from each other in the amount of detail incorporated into some sections and the amount of prescriptiveness in the legal requirements.

IADSA Global GMP Guide The WG worked electronically, with regular discussions held via conference calls. Many amendments to original documents due to semantics, where specific terminology has different meanings between countries or regions. A few terms used were amended or further clarifying terms added, in order to ensure greater understanding globally.

IADSA Global GMP Guide Different terminology globally (e.g. ‘food supplements’, ‘dietary supplements’, ‘health supplements’) so decision made to use term ‘supplements’. Due to different philosophies around the world, a section on HACCP is included as an Annex rather than a main chapter.

IADSA Global GMP Guide This Guide should be applicable for use by every supplement manufacturer across the globe, from the smallest independent business to the largest corporation, within the poorest country to the wealthiest. If manufacturers work to the IADSA GMP guidelines, the safety and quality of supplements around the world should be raised to a much higher standard.

Thank you for your attention! Sam Jennings, IADSA Technical Group spj@berryottaway.co.uk www.crnuk.org