Quality

Standard Process has always taken great pride in its quality control program. Since the good manufacturing practices (GMPs) for dietary supplements were published in 2007, many companies began to look at quality in the way that we at Standard Process have been doing for decades.

Our team of scientists, composed of highly trained and degreed microbiologists and chemists, work meticulously to guarantee our customers receive the highest-quality products. Our quality control unit ensures our label claims are met and testing is performed after critical stages of production to confirm our products are free of bacterial contamination. Additionally, shelf-life studies are conducted on each product to make certain that label claims are met throughout the life of the product.

Testing

Repeated testing on various stages of every batch throughout the manufacturing process enables us to ensure quality and safety of our products. On average, a batch is tested six times. Every week, our scientists in our full-scale quality control laboratory perform as many as 1,100 tests on raw materials, in-process product batches, and finished product. We use analytical methods that have been approved by nationally recognized evaluative bodies, including the Association of Analytical Communities (AOAC) and United States Pharmacopeia (USP).

Gluten

In conjunction with the research and development team, the quality control department has internally validated a method approved by the Association of Analytical Communities for gluten testing using the RIDASCREEN (Gliadin) by Biopharm. The testing consists of an enzyme immunoassay to quantify the prolamins that are found in wheat, barley, and rye. In order for a product to be considered gluten free, it would need to contain less than 20 ppm of gluten, according to Codex Alimentarius international food standards. Products listed in this guide with the designation are tested for gluten each time they are manufactured to ensure gluten-free compliance.

Laboratory Information Management System (LIMS)

Standard Process’ quality control department has fully validated and implemented the Laboratory Integrated Management System (LIMS), Nexxis iLAB by Labtronics. The system allows for a centralized storage location for all data analysis conducted by the laboratory. This implementation has improved data analysis by ensuring quality and accuracy of results, providing real time data retrieval, preventing data errors, automating manual calculations and allowing for lab data to be accessed throughout the facility.

Chemistry

Standard Process chemists perform multiple assays to guarantee that our products meet or exceed label claims and to ensure the viability of the product through its “best used by” date. We use the following instrumentation in testing raw materials and final product mixes:

The chemistry laboratory personnel also conduct wet chemistry tests for a variety of things, such as vitamin C, vitamins B1 and B2, pepsin, bile salts, water activity, moisture, carotene, iodine, phosphorous, and chloride. The vast testing capability of the chemistry laboratory allows Standard Process to verify the identity, purity, and strength of our products and of the raw materials used in our products.

Microbiology

Standard Process’ microbiologists perform pathogen testing on every product batch to ensure the products are safe to continue to the next stage of production. Testing is conducted on all facets of the manufacturing process, including raw materials, mixing, milling, tableting, capsuling, and packaging. Raw materials, in-process products, and final products are only released to the next stage of production by the quality control unit upon verification that the material or product has passed all testing requirements.

Tableting and Capsuling Process

Many tests are performed after the product is tableted or capsuled, including:

• Tablets are monitored for size, weight, water activity, and hardness. Hardness testing ensures that tablets remain intact throughout the packaging and shipping process.
• Capsules are monitored for size, weight, and water activity. Powders are monitored for water activity.
• Weights of tablets and capsules are verified to guarantee that label claims are met.

Farm

Soil samples are taken annually to determine mineral and nutrient levels in the soil. No synthetic fertilizers or pesticides are ever used in the organic growing process.

Learn More About

• Manufacturing
• Organic Farming
• Frequently Asked Questions