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Nutritional Supplement GMP StandardsQuality Safety Performance Freedom LifestyleThis topic of this page, Nutritional supplement GMP Standards is actually a sub-topic from my article Ingredient quality in nutritional supplements which deals with 'ingredient quality' as one of the key criteria that should be used when evaluating the true standard of supplements. That article lists several questions we need to ask of supplement companies in order to draw out often hidden information, allowing us to properly evaluate different supplement brands. Some of those questions come from an examination of the content on this page. To view all the questions please use the link above. Good Manufacturing PracticesEvery heard of Good Manufacturing Practices (GMP) ? They are regulations, enforceable by law, which were designed to ensure that manufacturers produce products which are safe, pure, and effective.But did you know there are different types of GMP! Supplements in the United States are currently regulated under ‘Food’ GMP which is a problem because this does not address the unique aspects of nutritional supplement manufacturing! Most supplement manufacturers in the USA follow Food GMP! Food GMP do not mandate ingredient testing!This has allowed numerous would-be supplement companies to churn out poor quality and in some cases dangerous supplements. Food GMP are primarily concerned with safety (that ingredients used provide a “reasonable certainty of no harm”) and sanitation.So while Food GMP provide some protection for supplement users, they do not require manufacturers to follow strict and expensive procedures, such as the quarantining and testing of each ingredient for purity, potency, and identity when it arrives at their facility. The 1994 Dietary Supplement Health and Education Act (DSHEA) dictated that the US FDA is to establish Good Manufacturing Practices (GMP) regulations which describe conditions under which dietary supplement ingredients and finished products must be prepared, packed and stored. These are expected to overcome deficiencies in food GMP by mandating raw ingredient testing - let’s hope so! But at this time ( 2006) these have still not been finished!! Until these are finalized, nutritional supplements only have to comply, by law, with ‘Food’ GMP. In the meantime some of the larger industry trade groups such as the National Nutritional Foods Association, and Council for Responsible Nutrition (CRN) are trying to advance the supplement industry’s credibility and cohesion by promoting unofficial GMP’s, exceeding food GMP standards, for their members to follow. This is encouraging but doesn’t reach far enough to prevent numerous disreputable supplement companies from churning out poor quality and ineffective nutritional vitamin supplements. Pharmaceutical Model GMPThere is a (very) small band of dedicated companies out there who are trying to make a difference and care about your safety. They have (voluntarily) established all or most of their manufacturing protocols in line with the strict ‘Pharmaceutical’ model GMP’s (Code of Federal Regulations – 21 CFR 210 and 211).These stringent regulations represent the highest standards possible and focus on safety, efficacy, purity and potency of raw ingredients and finished product. Compliance with Pharmaceutical-model GMP's gives consumers assurance that the supplements they consume meet stringent pharmaceutical standards for content, potency, and dissolution, and do not contain unwanted impurities. The choice to manufacture at this level essentially comes down to financial stability, integrity and an unshakable dedication to excellent quality and to producing the best vitamin supplements. Pharmaceutical GMP’s differentiate the best supplement companies and are the ultimate standards you want for any supplement you use. Bottom LineSmart supplement consumers only use products from supplement companies manufacturing in line with pharmaceutical GMP’s Other GMP levels allow too much variation in potency levels and composition of final products."Pharmaceutical Grade Processing Facility"Now, while I’m mentioning the word ‘pharmaceutical’ I’d like to explain the term “pharmaceutical grade processing facility”. This is plastered all over the internet and promoted by many companies in their marketing literature.Don’t be overly fooled by this. It only means that the manufacturing facility meets hygiene requirements. While this is in itself is an excellent standard it is no guarantee that sophisticated manufacturing procedures and Pharmaceutical GMP standards are being followed. Pharmaceutical grade facilities do however ensure the integrity of each ingredient and product. Important features include climate and positive airflow which is used to form a barrier from outside air when doors are open. The air is purified through filtration systems using HEPA filters. This is a totally different situation to so many of the contract manufacturers out there whose business consists exclusively of clients wanting basic, low quality supplements, and they don’t give a damn about the excellence (or lack thereof) of manufacturing standards. Just give them the product so they can sell it and make their money. Sorry to be so harsh here but I really want you to understand just how wide the range of quality is in the nutritional supplement industry and just how inferior (and sometimes harmful) the cheap bottom end products are. End: Nutritional supplement GMP standards
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