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A finished product is only as good as its ingredients, and a manufacturer is only as strong as its suppliers. A secured, properly-managed supply chain is the foundation on which a manufacturer's Current Good Manufacturing Practices (CGMP) compliance is built.
As the industry becomes immersed in the new era of CGMPs specific to dietary supplements, one of the key areas that will need to be addressed by dietary supplement manufacturers is supplier qualification. Supplier qualification involves a number of key elements that ensure that manufacturers are consistently supplying high-quality, safer products.
Vetting the Supply Chain
The dietary supplement industry's U.S. supply chain is complex, diverse, and global in scope, not unlike other industries'. And as with other industries, the problems that arise in the supply chain can cause concern and panic-or even lead to consumer-product recalls.
In recent years, we've seen a number of supply-chain issues throughout many industries, including lead in toys and E. coli in food. The supplement industry is affected by similar issues. Recent stories about supplements containing pharmaceutical actives and steroids come to mind, which have increased concerns about safety and quality.
In addition to addressing specific concerns about pharmaceutical actives and steroids, the supplements industry is also working to root out economically adulterated raw materials in general to keep them from entering the supply chain. Manufacturers need to be diligent throughout the manufacturing process and verify that the ingredients and materials they receive from suppliers are quality, unadulterated products.
This issue was recently raised when members of industry requested FDA's assistance in identifying companies that supply and purchase spiked and adulterated materials. Specifically, industry has asked that FDA require, under the dietary supplement CGMPs, that companies receiving products in manufactured form conduct testing to verify that identity and other specifications are met.
NSF INTERNATIONAL'S DIETARY SUPPLEMENTS CERTIFICATION program (based on the American National Standard for dietary supplements that NSF helped to develop) protects consumers by testing for contaminants and verifying that NSF-certified supplements contain the ingredients stated on their labels. If a product has been certified by NSF, it means that NSF has tested and verified its ingredients and manufacturing processes.
NSF's Athletic Banned Substances certification program is a similar certification program. It takes the dietary supplements certification program one step further by certifying sports supplements that have met NSF's certification guidelines. The certification program provides key preventive measures to protect against adulteration of products, verify label claims with product contents, as well as to identify any banned substances in a finished product.
Major League Baseball (MLB), the MLB Players Association, the National Football League (NFL), the NFL Players Association, the Professional Golfers Association of America (PGA), the Ladies Professional Golf Association (LPGA), and the Canadian Centre for Ethics in Sports (CCES) have all chosen the NSF Certified for Sport program to help ensure that the products their athletes use are safer.
DBA Analytical, an NSF International company, is a technology and life sciences contract research and consulting firm. It offers extensive testing and analysis for companies focused on product development in the fields of pharmaceuticals, dietary supplements, and food additives. DBA Analytical capabilities include New Dietary Ingredient (NDI) notifications, CGMP consulting, auditing and training services, stability studies in support of expiration dating, method development and validation, and label-claims verification.
What Goes Into Supplier Qualification?
There are two separate, but equally important, requirements of supplier qualification: testing and inspecting.
First, with regard to testing, if a manufacturer is relying on a supplier's certificate of analysis for incoming raw materials, the manufacturer will have to show, through analytical testing, that the incoming materials in fact meet their specifications. The manufacturer will also have to develop a statistical pattern and process for constantly monitoring incoming materials to ensure that they continue to meet specifications.
Another issue that can be monitored through testing is the economic adulteration of ingredients. This is an issue that can be resolved by knowing which ingredients are prone to adulteration or spiking and by properly screening incoming raw materials. While the many possible types of adulterants continually changes, manufacturers should be diligent in watching for adulterants that have been identified as being high-risk.
With regard to the second component of supplier qualification, inspection, it is essential to understand how your incoming raw materials have been manufactured. Audits and inspections can help. If working with overseas suppliers, an inspection of their facilities can lead to a stronger, more reliable partnership with your supply chain. It also gives manufacturers a better appreciation of the science and technology that is being utilized by quality ingredient suppliers.
If a supplier is unwilling to provide the information needed as part of a supplier-qualification program, or if incoming raw material is outside specifications, a manufacturer should consider replacing that supplier immediately.
Use of SIDI Documentation and Third-Party Certification
The dietary supplements industry has resources to assist manufacturers in building a solid supplier-qualification program for CGMP compliance. To date, many manufacturers have relied upon questionnaires and checklists as a means of gathering information to qualify a new raw material. However, that will no longer be enough to comply with the new CGMP regulations.
A number of ingredient suppliers are now providing the necessary documentation using a new industry initiative called the Standardized Information on Dietary Ingredients, or SIDI. The new SIDI protocol provides standardized guidance for manufacturers to use when requesting information from ingredient suppliers. It is also more comprehensive than just providing a certificate of analysis, as it includes guidance on all necessary information, including where and how an ingredient is manufactured, specification sheets, Material Safety Data Sheets (MSDS), test methodology, and other necessary statements and documentation. (Read more about SIDI in Nutritional Outlook's September 2009 issue.)
In addition to following SIDI, many ingredient suppliers are becoming CGMP-certified by an accredited third-party certifier, such as NSF International (Ann Arbor, MI), to demonstrate commitment to their customers' compliance needs.
Many manufacturers are reviewing their supply chains to verify whether their suppliers are CGMP-certified by an accredited third party, as it helps them to determine whether an audit or an inspection of that supplier is necessary. In many cases, the CGMP certification results in fewer inspections of an ingredient supplier's facilities, saving both time and money for the manufacturer and the supplier.
The issue of supply-chain management and qualification is complex and will take time and full industry participation to manage properly. However, the first steps must be taken immediately, as mandated by CGMP regulations.
Ed Wyszumiala is general manager of NSF International's dietary supplement certification programs, which includes NSF's Athletic Banned Substances program. He also manages NSF's CGMP program. Prior to his current role, Wyszumiala served as account manager for NSF's dietary supplement programs. Before joining NSF, Wyszumiala was COO of Graminex, a leading manufacturer of botanical products.