December 24, 2019
“Anyone can write a specification, but if nobody implements it, what is it but a particularly dry form of science fiction?”—Ian Hickson, specification editor of the Web Hypertext Application Technology Working Group (WHATWG)
The relationship between a brand owner and its contract manufacturers involves more than the delivery of the product. The details of the relationship are expressed in documentation. The requirements and responsibilities of establishing and meeting specifications for ingredients and finished products are among the most critical details. The specification controls the story of the product and provides the path for a product’s regulatory and consumer acceptance.
Legal requirements around specifications for foods and dietary supplements vary, but regardless of regulatory obligations, specifications are a solid business practice. They identify what is good about the product, and whether it meets the expectations of the brand whose name is displayed on the label. Capturing this information formally is logical and enforces a consistent product, while meeting regulatory criteria. That is all well and good and falls in the “Captain Obvious” category.
The technical ownership and meaning of these specifications, however, is not often recognized. The responsibility to establish specifications lies with the manufacturer. Brand owners may be responsible for maintaining them and may do this independently. This is often tied to the ownership of the formula itself. This are outlined in a quality agreement that clearly identifies the documents to be controlled by both parties. Among other things, the quality agreement should include and define ownership of the formula and approval of the product specifications.
A formula data sheet, which may parallel a finished product specification, outlines product formula parameters. This may include specification ranges for the active components, the packaging to be used and pallet configuration for shipping. The formula is identified, including the non-active ingredients. Any additional requirements regarding the use of bioengineered materials, use of trademarked ingredients, specific grades or potencies of ingredients are included.
Specifications are important. For dietary supplements, specifications are legally required to be established to ensure the identity, purity, strength and composition of the product. Brands also must test for known contaminants. Specifications are the most logical way to capture this information, but establishing specifications is a delicate balancing act. Testing is expensive, and not testing reduces costs, but missing a contaminate costs the most. Establishing individual parameters for any characteristic means that, according to the requirements of the regulations, the manufacturer must test against specifications.
The concept of “critical characteristics” is a conscious identification of the parameters that are critical to the function of the product, both in manufacturing and in the hands of the consumer. Each parameter included in a product’s specifications must be critical to the success of the formula; otherwise, including it has little financial justification. Performing that simple evaluation will result in meaningful specifications that can be continually evaluated to ensure effective manufacturing of quality products that meet marketing claims.
Specifications are necessary, sometimes mandated by regulation, and provide a valuable tool if employed correctly. The responsibilities for establishing these specifications and maintaining them must be identified when the product is manufactured under contract for a brand owner. Development of the specifications is the responsibility of the manufacturer, but the brand owner must know the requirements for the formula. Critical product characteristics and parameters for success must be determined and a given to the lab to test the specifications. Delineation of these parameters results in meaningful, agreed-upon specifications, which are the backbone of today’s regulatory and product quality framework.
As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.
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