As part of our GMP processes, specification sheets (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 specifications need to be met. Quality Control (QC) uses spec sheets to know what tests to perform on lab samples and also to determine whether or not those ingredients/products are acceptable to 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 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:
- Description - Including product name and the retail item(s) that the bulk product is used for as well as details of its functionality and product benefits.
- Specifications - Describes test methods and expected results for the strength, identification, and physical properties of the ingredient/product as well as tests methods and expected results for the presence of eventual contaminants/micro-organisms/heavy metals/adulterants.
Specifications are periodically revised due to changes in materials and revised formulas. Revisions may 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. 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, QC (Laboratories and Method Development), and supply chain among others 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.