Quality Control

Careful Steps to Perfect Products
Priority Number One: Quality Control

At the recent One of a Kind GeneWize Celebration, Dr. Donald J. Cannon reminded all guests how fully committed both GeneLink and GeneWize are to the precepts of quality control. Dr. Cannon who received his A.B. in Chemistry from Harvard College and a M.A. in Medical Sciences and a Ph.D in Biochemistry from Boston University is currently Professor of Chemistry and Director of the Forensic Sciences program at the University of Tampa. In addition to serving as Laboratory Director in Forensic Toxicology, National Manager of Operations Excellence and National Manager of Special Projects in Business Ventures at Quest Diagnostics, he has over 130 publications and has received numerous awards related to clinical laboratory medicine, laboratory management and teaching.

Standing at the podium, Dr. Cannon emphasized with his presentation that when you’re in the business of creating personalized solutions specifically designed to support each individual body, ensuring quality is priority number one.

That’s why at GeneWize, quality control takes center stage:

•Achieved by identifying failure, seeking the root cause and taking corrective/preventive action

•Infrastructure is in place (committee manuals, policies and documents).

•Gap Analysis continues to examine workflow paths.

GeneWize offers the only patented, FDA reviewed, non-invasive, self-administered DNA collection system available. The process is easy to understand, simple to do and takes just a few minutes. Simply swab the inside of your mouth (your inner cheek), and mail the swabs back to our laboratory in the special envelopes. Everything, along with easy-to-follow instructions and quality assurance, is included:
•DNA collection kits are bar coded and scanned for security and tracked throughout the process for quality control reporting using LIMS & Bio Informatics Tracking Systems

•All DNA Samples are destroyed after genotyping

•GeneLink is dedicated to protecting the privacy and confidentiality of all consumers information—No information is shared...Period

Once at the lab:

•All DNA samples are analyzed bi-directionally; meaning that both strands are tested in both directions and must agree

•Very few labs, if any, test both strands of DNA. This ensures our repeatability to over 99%.

•Sentinel samples & Coriell cell lines samples are included in every batch to insure quality control. These results must agree before our systems allow any batch results to be uploaded.

•Labs are Certified by CLIA & CAP

During the manufacturing process, quality control of individual ingredients prior to blending is the most important step:

•All ingredients are purchased from various reputable, well-established and high-quality manufacturers, most are vertically-integrated (farm processing).

•All ingredients are NSF GMP certified and tested for quality, purity,strength and consistency

•All macronutrients, nutritional compounds, vitamins and minerals, are USP/NF grade. (United States Pharmacopeia/ National Formulary)

•USP/NF is an official public standards–setting authority for all prescription, over–the–counter medicines and widely recognized food and dietary ingredients.

•A Certificate of Analysis (C of A) from all ingredient manufacturers is required for every individual ingredient and in-house retesting of these ingredients is conducted to confirm quality, including:

     ◦Heavy metal content

     ◦Color/appearance/odor

     ◦Microbiological testing (e.g. total plate count, pathogens, yeast and molds)

     ◦Moisture content

     ◦Particle size

     ◦Photochemical content

     ◦Extraction ratio (solvent to raw material ratio) Bulk and/or tap density

     ◦ORAC values (oxygen radical absorbance capacity)

Conclusion:

All the steps involved during manufacturing (formula blending, quality control testing, capsule filling) all have one goal in common - QUALITY!