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PRESTIGOUS ATESTS

PRESTIGOUS ATESTS
 
WHAT IS GMP ?
 
Good Manufacturing Practice – GMP, this internationally recognized acronym guarantees the best quality of products. GMP means that strict control and supervision has been introduced on every stage of the production process. Meeting all the requirements allowed the FDA (Food and Drug Administration) to give positive opinion to 4 life products, Perfect Nutrition and CaliVita companies, which products are distributed by CaliVita International.
 
Whys is GMP so important?
 
Following the rules of GMP is so important, because it guarantees that every product bought by the customer is effective, has no manufacturing faults, contains all substrates listed on the box and has no contaminations.
 
GMP is exceptionally important for food and pharmaceutical manufacturers.
 
Good Manufacturing Practice is a set of documents describing the desired quality level of the production procedures. It ensures that the manufacturers following those rules will promptly remove all defects and will not allow faulty product to be released.
 
The final quality of a product is a combination of some factors: raw materials used, overall state of the machinery and building of a factory, strict following the receipt, hygiene of the personnel, disinfections of machinery after the process is complete and the conditions of storing both raw materials and finished products.
 
GMP describes a set of requirements that needs to be met by the manufacturer. If just a single requirement is not met by a certain manufacturer, e.g. the raw materials are stored in an inappropriate way, then the manufacturer does not follow the rules of the GMP as whole and thus cannot use its logo.
 
Following all the rules set by the GMP allows a manufacturer to be given the FDA certificate.
 
FDA – WHY ITS OPPINION IS SO IMPORTANT?
 
Food and Drug Administration (FDA) – is the United States chief federal institution responsible for supervising and controlling all food and pharmaceuticals distributed on the American market. It is considered as one of the world’s most restrictive institutions regulating the drug market. This is why certificates issued by it are internationally recognized as an evidence of high quality and guarantee of having no negative influence on a patient.
 
Meeting all the requirements set by the FDA allowed it to issue a certificate confirming the high quality of all supplements manufactured by 4 life products, Perfect Nutrition and CaliVita and distributed by CaliVita international.
 
What requirements need to be met in order to get positive opinion?
 
The supplement needs to be produced according to the GMP procedures.
 
The product has to be closely examined by the FDA, which verifies its:
-         influence on the organism – whether the product is safe for use
-         labeling – whether it has proper information about dosage and contradictions
 
According to FDA a dietary supplement may contain the following substances: vitamins, minerals, amino acids, herbal extracts, enzymes, fish oils. The supplement should have the form of a pill, tablet, capsule or as a liquid. It must have a label saying clearly “dietary supplement” and cannot be described as conventional food product.
 
Remarks about other manufacturers
 
Since 1994, according to the resolution of the American Congress, dietary supplements are not a subject of the laws regulating drug production and as so do not need the FDA certificate. Nevertheless, manufacturers should inform their customers that their products do not passed the FDA control procedures.

All information on this website is of purely educational and informational nature and should not be treated as medical consultation !!! Authors, their consultants as well as the editors of the website are not responsible for any consequences of applying the information published on this website.

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