Dr. Donald J. Cannon, Ph. D

Quality Control

The Importance of Quality Control

• Verify the quality of testing and manufacturing to detect errors

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

• Operation must have an infrastructure in place .. Committee, manuals, policies and documents

• Gap Analysis .. Workflow paths

DNA Sample Quality Control• DNA collection kits are bar coded and scanned for security and tracked thought 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

DNA LAB Quality Control• 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

Ingredient Quality Control

• Quality Control of individual ingredients prior to blending is the most important step of the manufacturing process.

• 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.

Ingredient Quality Controlled Cont.• All macronutrients, nutritional compounds,

vitamins and minerals, are USP/NFgrade. (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.

• Quality

• Purity

• Strength

• Consistency

Ingredient Quality Control Cont.

• A Certificate of Analysis (C of A) from all ingredient manufacturers is required for every individual ingredient and shipment.

• In house retesting of these ingredients is also conducted to confirm quality– 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)

Manufacturing Quality Control

• Base and SNP Boost™ formulas are manufactured in our FDA-compliant facility.

– Follows strict GMP (Good Manufacturing Practices) guidelines for Dietary Supplements.

• Following production, all formulas are tested and quarantined until Quality Control signs-off on a Certificate of Analysis (C of A).

• Individual formulas are blended using a proprietary titration system that customizes the amounts of Base formula and SNP Boosts™ into vegan capsules.

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Formula Blending Quality Control Testing Capsule Filling

Quality Control Summary

• Quality Control (QC) is part of a system known as Quality Assurance (QA)

• QC are techniques and activities used to fulfill quality requirements

• QA is systematic activities that are implemented in a quality system so that quality requirements for a produce or service are fulfilled