INTRODUCTION
A Food supplement is defined under European Union (EU) legislation as ‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders’.
As set out in or service page relating to GPM for Food Safety Management GMP stands for Good Manufacturing Practices, which are a set of guidelines designed to ensure the safety and hygiene of food production throughout the entire food chain. These guidelines establish requirements for management and handling actions, as well as the design and operation of establishments and processes related to food production.
However, Food Supplements have some additional requirements “Food Supplements Europe Guide to Good Manufacturing Practice for Manufacturers of Food Supplements”
The aim of this document is to produce guidelines which address the specific needs of the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU food legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document apply also to food supplement companies whose products are contract manufactured and also to those who are solely distributors of products.
Examples of GMP guidelines include the construction and layout of food premises, employee training, equipment maintenance, appropriate chemical use, effective pest control, waste identification and storage, implementation of traceability systems, and cleanliness of premises and equipment.
Audit schedule
Audits can be based on a one-off audit usually conducted annually.
However International Associates have developed a Quality Management System QMS approach using a 3 year cycle of initial certification followed by 2 annual surveillance visits. This allows the verification of the system over the 3 years reducing the audit time and costs based on the internal controls by the company. (This approach is based on the ISO standard for GMP ISO 22716 and the Food Supplements Europe Guide to Good Manufacturing Practice for Manufacturers of Food Supplements, mentioned above)
