Posted on Nov 02, 2012 | Comments 0
Dietary supplements can be rendered safe by using quality by design (QbD) model. This is the conclusion reached by researchers at the University of Mississippi.
This is published in the recent issue of the Journal of Natural Products.
The authors of the study, Dr. Ikhlas Khan and Dr. Troy Smillie have mentioned in the paper that applying this technique to the development and then to the manufacture of herbal dietary supplements will make them safer in the eyes of the consumers.
Manufacture of Dietary Supplements
Till date dietary supplements are governed under the foods section of the USFDA, thus making it the liability of the manufacturer to make good quality and safe supplements.
Hence, they need not require approval from the FDA to market supplements containing ingredients that are generally considered safe. However, this is raising issues regarding safety of herbal dietary supplements and the variation in the quality of the same product from different companies.
Quality by Design Model (QbD)
To solve this problem the scientists have published a paper describing the various analytical techniques that one can use to ensure the use of high quality raw materials and excipients in the production of a drug. These include the classic techniques to the most modern ones that one can adopt during the manufacture of a drug.
Further, the scientists suggest that these techniques be applied right at the drug discovery and development stage. This will ensure that the manufacture of the right drug happens in line with its development. The final result would be a fine and safe product that would also be marketed using the same quality by design rule.
QbD v. GMP
GMP is nothing but Good Manufacturing Procedures. This ensures that the manufacture of the product happens using the best raw materials and techniques possible. QbD however, ensures that these good procedures are followed even in the development process. So the final product has quality etched in every level of its production.
Hence, following QbD in herbal dietary supplement manufacture is recommended to make the supplement market more reliable.
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