Start at the Source: Five Steps to Improving Control of Your Infant Formula Supply Chain

Covance Nutritional Testing Baby Formula

Who do you trust with your brand? If you are not properly testing your raw materials, your brand’s reputation may be at risk.

Infant formula is one of the most highly regulated products in the world—and with good reason. As often the sole source of nutrition for infants, your end products must be unquestionably safe and consistent.

Often, manufacturers test only their end products for adherence to quality and safety standards. This approach can be inefficient and does not offer solutions to recurring problems. By assuring proper testing of your raw materials, you gain confidence in your suppliers’ Certificates of Analysis, minimize risk and increase efficiency of production.

When manufacturing infant formula, you have more than food safety to think about. Managing regional differences in your global supply chain, maintaining consistency through seasonal variability and refining your process for efficient production are only a few of your challenges. The following five steps will help you strengthen management of your supply chain.

1. Conserve resources with early nutrient testing

Many nutrient deficiencies can be identified early in the manufacturing process by a thorough and consistent raw materials testing program. By catching these problems in advance, you can avoid expensive losses of time and resources.

All testing laboratories and all testing methods throughout your manufacturing process must be qualified. It is important to assure that only approved testing methods such as AOAC, ISO, CEN or Codex are utilized when testing your products. Since maintaining in-house labs can be expensive, an independent third-party lab may be the best choice.

2. Mitigate risk with prompt microbiological eradication

An undetected pathogen can contaminate large quantities of your ingredient and your end product. To protect your brand, all raw materials should be screened for major pathogens.

To test for microbiological contaminants, HCAAP and other safety protocols must be standardized and implemented. After screening, consistent routine protocols should be followed to ensure all materials are stored and dispensed aseptically.

3. Start and end with chemical-free raw materials

Even trace levels of pesticides, heavy metals and other chemical contaminants can put your brand at risk. Many of these contaminants have long-term residual effects.

When testing for heavy metals in your raw materials, geographic origin should be considered. Use only validated testing procedures to ensure that all chemical contaminants meet the levels of quantification specified.

4. Gain efficiencies by using a risk-based protocol

Partnering with a testing laboratory that is educated about the risks of each potential contaminant allows you to design a testing program that achieves superior quality and safety levels in an efficient, cost-effective manner.

Be sure your testing laboratory is utilizing efficient and accurate screening methods. Combining targeted and non-targeted analysis to identify potential issues is also important. Only perform comprehensive testing to confirm the presence of potential contaminants identified by your screening process.

5. Secure your future by building relationships with your suppliers

All vendors are not created equal, nor are all third-party testing laboratories. It is important to be informed about your suppliers and the testing laboratory they use in order to maximize a risk-based approach to testing. Test all raw materials from new vendors, and develop quality agreement contracts. For qualified vendors, you may consider a blind testing program for ongoing surveillance. It is always important to use a statistically sound sampling program.

It is important to understand that supplier labs may not be reliable. In-house labs can be inefficient and expensive to maintain. A qualified third-party testing laboratory should be able to partner with you and offer scientific expertise and resources to implement all of these important elements of supply chain management.

For a full in-depth course on this subject, view our webinar, “Five Steps to Stronger Management of Your Infant Formula Supply Chain”:

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About Darryl Sullivan

Darryl Sullivan is the Director of Scientific and Regulatory Affairs for the Nutritional Chemistry and Food Safety Division at Covance Laboratories. Mr. Sullivan acts as the primary liaison with food, nutritional and dietary supplement companies as well as providing expertise on designing comprehensive testing programs to meet scientific and regulatory requirements. In this role he is often called upon as an expert witness for litigation and dispute resolution. He has managed numerous different departments at Covance including lab operations, research and development, client services, sample management, sample preparation and study direction, as well as a satellite laboratory in Michigan. Mr. Sullivan received his BS from the University of Wisconsin-Madison and has more than 30 years of experience in laboratory testing of food and dietary supplements. He is considered to be an expert in the field of validation of analytical methods, having served for three years as Chair of the AOAC INTERNATIONAL Official Methods Board. Mr. Sullivan was a member of the Task Force that redesigned the AOAC Standards Development Process. He is currently the Past President and Secretary of the AOAC INTERNATIONAL Board of Directors, and the Chair of the AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals. He is also the Chair of the AOAC Stakeholder Panel on Dietary Supplements. He is a former member of the Board of Directors of the AOAC Research Institute. He is the Chair of the Analytical Laboratories Committee of the American Herbal Product Association, a member of the USP Council of Experts for Dietary Supplements, and is a member of the Joint Committee on Dietary Supplements of NSF. Mr. Sullivan has developed and validated hundreds of analytical methods in the areas of nutrient and residue testing, and is the author of more than 75 publications and 100’s of scientific presentations. In addition, he is the Past Chair of the AOAC Presidential Task Force on Dietary Supplements and co-editor of the book Methods of Analysis for Nutrition Labeling. He is also the co-editor of the book Improving Import Food Safety.