Manufacturing of supplements

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This introductory guide to tolerances has been developed to achieve a better understanding of the issues surrounding product tolerances and to explain in some detail the many causes of variation that can occur in the raw materials, formulation and processing. This IADSA guide is essential reading for both manufacturers and regulators as it explains the concept of product tolerances and gives practical advice on identifying and minimising the variances at all stages in the life of a product.

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‘Stability Testing for Shelf Life Determination of Supplements’ is part of a series of Technical Guidance for the supplement industry, which have been produced by the IADSA Technical Group over the past few years. ‘Stability Testing for Shelf Life Determination of Supplements’ outlines the principles for setting up scientifically based stability studies, which are specifically designed to assess the stability and potential shelf life of supplements. It discusses the various important aspects that need to be taken into consideration when designing a stability study. This document should be read in conjunction with the IADSA ‘Global Guide to Good Manufacturing Practice for Supplements’ and ‘Shelf–life Recommendations for Supplements’.

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As part of good manufacturing practice, products should meet specifications throughout their shelf-life, and are generally labelled with a date through which the product’s potency is assured by the supplement manufacturer. These guidelines on shelf-life recommendation provide information on factors that could affect shelf-life, parameters to be taken into account for shelf-life testing and sources of data that can be used or need to be developed to assist manufacturers in defining and supporting the shelf-life dates of their products.

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Through long-established industry practice, an ingredient supplier typically provides customers with a Certificate of Analysis (COA) with each delivered batch. The goal of this publication is to present recommendations on the content and format of such COAs including: specifications for identity and, as applicable, specifications on other characteristics such as purity, strength, composition and appropriate limits for ingredients in which there is a known or reasonable expectation that a contaminant or adulterant may be present. These guidelines are applicable to all supplement ingredients used in the manufacture of a supplement product.

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The ‘Global Guide to Good Manufacturing Practice for Supplements’ provides guidelines for the promotion of best practice in the production of supplements, including manufacturing, quality control, packaging, distribution and storage. An important tool for both companies and governments worldwide, the guide covers quality management, premises and equipment, personnel and training, product and process development, manufacture, storage, transport and distribution. It also gives recommendations in areas critical to the manufacture of high quality products, including the recovery or re-working of materials, documentation, self-inspections, sub-contracting operations, laboratory testing, complaints procedures, product recall and emergency procedures.

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