The Food and Drug Administration?s much-anticipated new cGMPs will initially be a strain on food manufacturers, and especially on ingredients suppliers, Qun Yi Zheng, PhD, believes, but in the end they will be a huge step forward in the process of restoring the industry reputation
The Food and Drug Administration?s forthcoming Current Good Manufacturing Practice (cGMP) in manufacturing, packing and holding of dietary ingredients and supplements will set new standards that will validate the nutraceuticals industry.
This change will have a profound effect throughout the industry by raising the bar on the quality of suppliers and manufacturers, and levelling the playing field among these companies. This will further improve the quality of products to the end consumer, improving the efficacy of products and ultimately bringing added trust and loyalty to the industry.
The new cGMPs, which are expected to be finalized sometime this year, will revamp certain guidelines for the dietary supplements industry. While the FDA has already enforced similar guidelines for the food and pharmaceutical industries, dietary supplements have yet to be regulated in this way on the federal level. These regulatory requirements provide guidelines for necessary processes, procedures and documentation to assure the product produced has the identity, strength, composition, quality and purity it is said to possess.
In this industry, following good manufacturing practices is a vital procedure in obtaining high-quality products. Since dietary supplements are becoming more popular worldwide, the quality of those products becomes even more critical for companies involved in their manufacture. Therefore, the purpose of the new cGMP issuance is to ensure the quality of finished goods delivered to the customer.
While we all know the importance of raw materials to a high-quality product, raw materials are, in fact, the foundation of a product. Without a qualified material, all efforts in producing a good product would be akin to building a palace on a sandy base. We can thus expect that the new cGMPs will have the greatest impact on raw materials suppliers.
Currently, suppliers have a number of certifications and practices they can use to prepare themselves for compliance with the new standards. For example, NSF International runs a GMP certification program that provides outside auditing and third-party approval on raw materials, from grower through production. The FDA audits facilities in a similar way.
Overall, the change in standards will have an effect on which manufacturers remain in the industry. Suppliers will be implemented to cover all stages of manufacturing, packaging, labelling, and holding of the ingredients and products. As high-quality raw materials tend to be more expensive, these will be the only ingredients available to manufacturers.
No longer will a supplier be able to provide an ingredient without following the proper standard operating procedures to ensure that this material meets their manufacturer?s every specification. Suppliers will have their quality-control scientists analyze botanicals for microbial contamination, aflaxtoxins, heavy metals, pesticide residues following USP guidelines and use of irradiation. In addition, a product would not be shipped out of a facility without passing every analysis for purity and potency. Likewise, a manufacturer would not be able to find an ingredient that does not match precisely what their customer is looking for.
The cost of high-quality raw materials will adversely effect the cost to the manufacturer. Those manufacturers who are not able to adjust to these costs will find themselves out of the industry. All of the changes following the announcement of the new cGMPs will ultimately have a positive affect on the industry. Without having low-end, potentially ineffective products on the market, customers will begin to regain trust. They will have confidence in nutraceutical brands, knowing that purchase after purchase, they are buying the same quality product they know to be beneficial.
The announcement of the new cGMPs will be a huge leap in the right direction for re-establishing ourselves in the minds and hearts of our customers.
Qun Yi Zheng, PhD, is president and chief operating officer of Pure World Botanicals, an NSF-certified and FDA-audited facility for manufacturing active pharmaceutical ingredients. www.pureworld.com
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