Now more than ever, raw material qualification has to be a priority for manufacturers. Qualifying raw materials has everything to do with producing a quality finished product that is safe and effective. While it used to be common practice for a manufacturer to accept a certificate of analysis (CoA) from an ingredient supplier at face value and not delve further, today that is viewed as reckless. There are several specific aspects of raw material qualification that must be addressed to meet GMP requirements and to demonstrate commitment to safety and efficacy.
Safety of dietary ingredients is the most important issue that must be addressed to make certain that incidents of contamination or adulteration of material do not occur. The U.S. industry experienced several notable adulteration instances, either accidental or intentional, that have had lasting impact. Both types of adulterations are failures in the supply chain. This has resulted in stricter federal regulations on manufacturing supplements.
Establishing supplier reliability begins by confirming the supplier's CoA, which must include: a description of the test methods used; the limitations of the test; the specifications requested; and the actual test results that meet the specification. In addition, the manufacturer must keep records of how the supplier was and is being qualified. The manufacturer's quality control (QC) department must review, approve and keep records of all documentation sent by the supplier. The QC manager should check with the United States Pharmacopeia (USP) and other sources to see whether the method of analysis used is appropriate for the particular raw material. This is crucial, because if methods are not validated and appropriate (fit for purpose) for the material being tested, the results are meaningless.
The problem manufacturers are facing is a lack of GMP regulations for raw materials produced in other countries, which may amount to more than 90 percent of raw materials used in dietary ingredients today. The responsibility falls on U.S. manufacturers to verify a supplier's GMP compliance through a GMP rule called “supplier qualification." Therefore, manufacturers and suppliers need to set up a rigorous supplier qualification program and GMP auditing program in the face of a complex, globalized supply chain.
However, U.S. manufacturers and distributors are confused by what actually constitutes a sufficiently rigorous supplier qualification program. There is no uniform or well-defined qualification system of imported raw materials existing today. The raw material suppliers’ response to this challenge ranges from doing nothing at all to desk audits, third-party audits or physical audits, which include extensive ingredient testing. This situation is caused, in part, by the vagueness of the supplier qualification rule.
FDA GMPs were not based on the unique and varied production or processing of dietary ingredient raw materials, but were based on treating dietary ingredients as a special class of foods and regulating them accordingly. Dietary ingredients are uniquely subjected to both food regulations and dietary ingredient regulations.
Food Safety Modernization Act (FSMA)
Raw material suppliers must also comply with the Food Safety Modernization Act (FSMA), which focuses on sanitary practices and conditions, including personal hygiene, equipment, overall facility hygiene and further cross-contamination controls. The impact of the law is now being explored by raw material suppliers for compliance based on HACCP (hazard analysis and critical control point) planning, which identifies biological, allergenic, physical and chemical possible contamination sources during the processing of raw materials. The regulation also requires risk reduction strategies once a potential contamination source has been identified.
Customer requirements must also be met by raw material suppliers, including batch CoA using the most appropriate method of analysis for the raw material, facility self-inspection, self-audit and QC certifications to prevent contamination as part of the supplier qualification program.
The Impact on the Cost of Raw Materials
Multiple inspections of the same category by a raw material supplier’s numerous customers adds to the cost of raw materials by increased downtime and personnel hours. Sending auditors to the raw material supplier can be extremely expensive given the global marketplace and further adds to the cost of the finished product. This cost can be reduced by using third-party auditors stationed in the target country of manufacture, but this auditing begins to fall into a gray area of product liability and regulatory vagueness. No specific worldwide GMP registration program existed before the newer regulations went into place, and there are more questions than answers given this environment.
One solution to this new international regulatory environment is third-party auditing, such as NSF International’s Dietary Ingredient GMP program, which adheres to 21 CFR GMP requirements. Additional requirements of the program include recall capability and full accountability of raw material sourcing.
Often times, raw material suppliers who do not have built-in quality controls force the additional costs into the material cost and, ultimately, the finished product cost passed on to the consumer.
End Result Must Be Safety and Efficacy
Companies need to decide if they are quality-oriented or price-oriented. Gone are the days when you could be both. Also, shopping around for the lowest-priced active ingredients sounds beneficial to all parties involved, until a physical audit takes place and the old saying, “you get what you pay for" becomes a reality. Sourcing low quality ingredients is short-term thinking. Ultimately, when you undergo all aspects of raw material qualification, you must come to know what you are putting in your products.
Shaheen Majeed, marketing director, Sabinsa Corp., has handled a variety of sales positions, representing the company's substantial portfolio of proprietary nutritional and cosmeceutical ingredients, which included US Tri-State region sales, California Sales Manager, and Latin American Business Development, a responsibility he still handles in addition to his current role.