Page 26 - August 2019 SP Product Guide

About Us Quality Control: Comprehensive and Meticulous

Another way Standard Process is a leader in the
batch is tested six times. Every week, our scientists in
supplement industry is through its quality control
our full-scale quality control laboratory run as many
program. In fact, since the good manufacturing
batches, and finished product. We use analytical
practices (GMPs) for dietary supplements were as 1,100 tests on raw materials, in-process product
published in 2007, many companies began to look at methods approved by nationally recognized
quality in the way Standard Process has been doing evaluative bodies, including the Association of
for decades. Analytical Communities (AOAC) and United States
Pharmacopeia (USP).
Our quality control laboratory recently earned
ISO 17025:2005 accreditation for Determination Gluten
of Metals, Direct Yeast & Mold, Coliforms, and We pay special attention to ensuring that the products
E. coli. Laboratories who receive this accreditation we label as “gluten-free” are indeed gluten-free. In
have demonstrated that they are technically conjunction with the research and development team,
competent and able to produce precise and accurate the quality control department has internally validated
tests and calibration data. In order to be accredited, a method approved by the Association of Analytical
third party auditing was conducted to ensure Communities for gluten testing using the
adherence to all requirements of the standard. RIDASCREEN® Gliadin by R-Biopharm. The testing

Our quality control team consists of highly trained consists of an enzyme immunoassay to quantify the
microbiologists and chemists who work prolamines that are found in wheat, barley, and rye.
meticulously to guarantee our customers receive In order for a product to be considered gluten-free by
quality products. This department performs testing U.S. Food and Drug Administration standards, it needs
after critical stages of production to ensure our label to contain less than 20 ppm of gluten. Products listed
claims are met and confirms products are free of with this GF designation are tested each time they are
bacterial contamination. Shelf-life studies are also manufactured to ensure gluten-free compliance.
conducted on each product to make certain that label
claims are met throughout the life of the product. Laboratory Information
Management System (LIMS)
Quality Assurance Standard Process’ quality control department has fully
We use high-performance thin-layer validated and implemented the Nexxis iLAB laboratory
chromatography (HPTLC) to identify incoming raw integrated management system (LIMS) by Labtronics.
materials and in-process materials and qualify them The system allows for a centralized storage location for
based on consistency, potency, and purity. HPTLC is all data analysis conducted by the laboratory.
used to create a unique banding pattern, or
“fingerprint,” by isolating key chemical constituents
to aid in identification of these materials.
High-Performance Liquid Chromatography (HPLC)
Quality Audits vitamins A, E, B , B , C, D; niacin; folic acid
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We work very closely with our suppliers, using a
questionnaire for qualification and an auditing Gas Chromatography (GC)
solvents
program designed to ensure quality. Planned site
visits are conducted 12-14 times per year based Inductively Coupled Plasma (ICP)
on risk analysis. Our purchasing department minerals, heavy metals
evaluates on-time delivery, customer service, High-Performance Thin-Layer Chromatography (HPTLC)
invoicing, and more. botanical identification

Testing Fourier Transform Infrared Spectroscopy (FTIR)
Testing of every batch is repeated in various stages raw material identification
throughout the manufacturing process to ensure LECO®
quality and safety of our products. On average, a protein analyzer

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26 Whole Food Nutrient Solutions | standardprocess.com | 800-558-8740