Nutraceutical manufacturers find in BatchMaster software solutions, the best partner for sustaining their growth and productivity, in the midst of increasing popularity of their products around the globe and stringent FDA compliance requirements.
Last many years has seen a big boom in the Nutraceutical market. Prevalence of dietary supplement usage has increased all over the world. Since 1990, an average annual growth rate of Nutraceuticals has ranged from 14% to 20% and with annual sales currently exceeding $20 billion. Scientific studies on prevalence and surveys conducted in the United States suggest that more money is spent on dietary supplements than on conventional pharmaceuticals. In the adult U.S. population overall, one-year prevalence of dietary supplements estimates range between 73–85%, with ∼40–60% of Americans being regular users. The vast majority of users (85%) take vitamin and mineral supplements, but 24–42% of users report taking herbal products and other botanicals.
Interestingly, the original term of a Nutraceuticals or Dietary Supplement as a product to supplement the diet by increasing the total dietary intake for maintaining good health has been extended and claims of its usage in preventing chronic diseases have also emerged. Although preventing chronic disease, is a relatively new phenomenon in comparison to the long history of human nutrition and studies of nutritional deprivation. For example, the use of supplemental vitamins, iron, and other minerals has been widespread for more than 50 years. Indeed, Western populations have revolved around the concept that nearly everything can be provided in a pill or a capsule. By contrast, the perception that foods themselves are beneficial and can provide much greater clinical and biochemical improvements to patients than pills is a relatively new finding. Clearly, the whole is better than individual components; that is, consumption of diets rich in antioxidants, such as green vegetables, is far better than taking a dietary antioxidant tablet. Although this concept may seem obvious to most scientists and physicians, it is still not as widely accepted in the general population as one would expect. Indeed, one has only to go through the shelves in pharmacies and grocery stores to appreciate that.
At the customer front expectation remains that dietary supplement to be affordable, accessible, and safe. However, the legislative history of dietary supplements reflects an ongoing battle to reach a compromise between these partially conflicting demands of affordability and safety. The situation becomes complicated because of the fact that there is big diversity in Nutraceutical manufacturers, manufacturing processes, and quality control issues are enormous. As with all plant products, herbal products are complex mixtures of a variety of chemical constituents with considerable variation in the growth, harvesting, and storage conditions, including different extraction procedures. Furthermore, not only there is a variation in batches, but also there is the potential for contamination.
In 2007, FDA announced a final rule establishing regulations to require cGMP for dietary supplements, the Dietary Supplements Final Rule. The Dietary Supplements Final Rule is aimed to ensure dietary supplement quality, purity, consistency, and safety, and to ensure that dietary supplements do not have wrong ingredients, too little or too much of a dietary ingredient, improper packaging, improper labeling, and contamination problems due to natural toxins, bacteria, pesticides, glass, lead, or other potentially toxic substances. All of this is to ensure consumers that they are getting accurately labeled and unadulterated dietary supplements.
As a result of Dietary Supplements Final Rule all Nutraceutical manufacturers have to meet the following outlined requirements:
1. Labeling requirement: DSHEA defines a dietary supplement as wrongly branded if the label fails to list the name of each ingredient and its quantity or if the supplement fails to meet the quality, purity, or compositional specifications that the supplement is represented to meet. Wrong branding can result in legal action by the FDA or the FTC (responsible for advertising material).
2. Adherence to cGMP regulations: cGMP regulations require manufacturers to establish specifications for identity, purity, quality, strength, and composition of their products and to institute the necessary quality control measures.
3. Preparedness for instant recall: Since there is no pre-market approval requirement for dietary supplements, except those with new dietary ingredients, the FDA has to rely heavily on the reporting of adverse events as a signal of possible public health concerns. Hence they strongly recommend that the Nutraceutical manufacturers to be completely prepared in case of any eventuality.
4. Quality control: the regulations re- quire manufacturers to establish specifications for the identity, purity, quality, strength, and composition of their products and for the components used in the manufacturing process. They further require the manufacturer to institute the necessary quality control measures to make sure that the specifications are met. These provisions, if vigorously en- forced, would go far in helping ensure that a product contains what is listed on the label in the amount specified on the label without contaminants and adulterants.
BatchMaster for Nutraceuticals is a mature process ERP software designed and developed to cater the specific business and above mentioned regulatory needs of Nutraceutical manufacturers. BatchMaster for Nutraceuticals has inbuilt dynamic functionality which provides complete control over the inventory, manufacture, sales, and purchase. Execution of these functional activities has been designed in accordance with the regulatory cGMP expectations. Moreover, the software also permits its users to analyze and prints the nutritional content of ingredients using a standard USDA ingredients database.
It provides nutritional analysis of Formula ingredients for simple, quick product information analysis and product labeling while meeting the compliance standards of US labeling requirement. BatchMaster also has advanced features like Allergen Management, Kosher, and Halal Management. It also has inbuilt forward and backward traceability features which permit its users to keep complete track of their products ranging from sources of the raw materials to distribution status of the finished products in the supply chain. Complaint received for any product can be traced back by lot explosion to get the complete product structure, lot of raw materials used and the list of the customers who have received those lots. As a result of this functionality, recall of the products is quicker and avoids hardships to both manufacturers as well as consumers. Furthermore, BatchMaster for Nutraceuticals provides the options of quality checks of the raw materials, in-process and finished products. It will not permit the use of the unqualified QC products in the system during its inclusion in inventory, release to manufacturing and release as finished product.