By Kim Newman, QA Department, NOW Foods
As part of our GMP processes, specification sheets, or spec sheets, are created, maintained and updated for all single raw materials, mixtures, capsules, tablets, softgels and liquid products. These spec sheets provide us with specific information regarding the product so we know exactly what specifciations need to be met. Quality Control utilizes the spec sheets to know what tests should be performed on lab samples and also to determine whether or not those ingredients or products are acceptable and can be released for sale. Our Nutritionists also access the spec sheets in order to provide information to consumers.
How is the information collected?
Quality Assurance (QA) creates the spec sheets with the information that is gathered from our Research & Development (R&D) department, scientific studies, vendor information and historical data. When a spec sheet is created for a new material, we research background information about the composition of the material, as well as testing methods and standards. QA uses this information, along with the results that QC has documented, to create the data that results in the spec sheet. The spec sheet is divided into the following sections:
Product Summary - This section will state the name of the product and the retail item or items that the bulk product is used for. It may also describe in some detail the functionality of the product and benefits it may provide to the consumer.
Ingredients -If the product is a capsule, tablet, softgel or any product that contains a mix of several components, the Ingredients section would display the formula. Included in the Ingredients section are the item numbers of all the individual components, the names of those components and the label claims of those components in the formula.
Specifications -The heart and depth of the spec sheet rests in this section, where the tests that are performed on each product are displayed. The left hand column of the spec sheet lists all of the test names, such as Color, Odor and Moisture, as well as other pieces of critical information. The middle column lists the specification (maximum or minimum number, a range of numbers, or a statement) that must be met. Finally, the right hand column lists any applicable testing methods that are used to carry out the tests listed to the left.
Specifications are periodically revised due to changes in materials and revised formulas. A few reasons to make revisions on a spec sheet include adding an additional supplier, tightening or expanding acceptable ranges (mostly due to varying particle sizes of the powders), or including additional value-added testing. When a spec needs to be revised, R&D will evaluate the material and determine what the new testing protocol should be. For new suppliers, typically the Purchasing department initiates the request, then QA, R&D and other departments ensure that the new supplier can meet the specifications, and then QA approves the changes. A revision note is added into the spec sheet for internal tracking purposes and the reason for the revision is kept on file for reference.
Overall, QA is responsible for all spec sheet maintenance and works closely with R&D to ensure that all of the information is accurate, up-to-date and consistent with similar materials. The quality of our products is our company’s top goal, and maintaining all of our product specification sheets is one way to ensure that NOW products continue to pass all of our rigorous quality standards.