Page 16 - February 2019 Veterinary Product Guide

About Us Quality Control: Comprehensive and Meticulous

Another way Standard Process is a leader in the
supplement industry is through its quality control batch is tested six times. Every week, our scientists in
our full-scale quality control laboratory run as many
program. In fact, since the good manufacturing as 1,100 tests on raw materials, in-process product
practices (GMPs) for dietary supplements were batches, and finished product. We use analytical
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 of Gluten
Metals, Direct Yeast & Mold, Coliforms, and
E. coli. Laboratories who receive this accreditation We pay special attention to ensuring that the products
have demonstrated that they are technically we label as “gluten-free” are indeed gluten-free. In
competent and able to produce precise and accurate conjunction with the research and development team,
tests and calibration data. In order to be accredited, the quality control department has internally validated
third party auditing was conducted to ensure a method approved by the Association of Analytical
adherence to all requirements of the standard. Communities for gluten testing using the
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
quality products. This department performs testing In order for a product to be considered gluten-free by
after critical stages of production to ensure our label U.S. Food and Drug Administration standards, it needs
claims are met and confirms products are free of to contain less than 20 ppm of gluten. Products listed
bacterial contamination. Shelf-life studies are also with this GF designation are tested each time they are
conducted on each product to make certain that label manufactured to ensure gluten-free compliance.
claims are met throughout the life of the product.
Laboratory Information
Quality Assurance Management System (LIMS)

We use high-performance thin-layer Standard Process’ quality control department has fully
chromatography (HPTLC) to identify incoming raw validated and implemented the Nexxis iLAB laboratory
materials and in-process materials and qualify them integrated management system (LIMS) by Labtronics.
based on consistency, potency, and purity. HPTLC is The system allows for a centralized storage location for
used to create a unique banding pattern, or all data analysis conducted by the laboratory.
“fingerprint,” by isolating key chemical constituents
to aid in identification of these materials.

Quality Audits High-Performance Liquid Chromatography (HPLC)
vitamins A, E, B , B , C, D; niacin; folic acid
We work very closely with our suppliers, using a 6 12
questionnaire for qualification and an auditing Gas Chromatography (GC)
program designed to ensure quality. Planned site solvents
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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