Journal of ARIIX Quality Vol 2 No 3, March 2019
For the past two messages, we’ve discussed ARIIX Quality as a professional discipline, along with some of the primary tools used in this pursuit. To continue this discussion, this month we’d like to focus on two additional tools used in the discipline of Quality — namely, Documentation and Records.
While these words may be interchangeable in common use, in the world of manufacturing, quality, and regulatory compliance, there is a small but significant difference between Documentation and Records. In this context, Documentation (or documents) includes all written specifications, procedures, instructions, communications, records and other information about products or the processes related to said products.
In the context of manufacturing, quality and regulatory, Records are any information written down about a specific product, process or occurrence.
The US FDA uses the following definition of Documentation: “1) the supplying of documents or supporting references; use of documentary evidence; 2) the documents or references thus supplied; 3) the collecting, abstracting, and coding of printed or written information for future reference.”
FDA further explains, “Documentation creates a mechanism that shows how products are manufactured and tested. Documentation should define your organization’s processes and capture every aspect of your manufacturing process. Documentation prevents errors of interpretation or loss of information that may result from reliance on verbal communication. Documentation also allows you to trace where any problems may have occurred and to take appropriate corrective action.” 1
In Manufacturing, and in Quality specifically, Documentation and Records are perhaps the most important tools, as nearly everything we do in this industry involves either the creation of or the use of documents and records (quite often it’s both!). Examples of the creation and/or use of Documentation and Records in Quality and Manufacturing include (but certainly are not limited to) the following:
• Product Formulas
• Specifications — Ingredients and Finished Products
• Batch Production Records
• Standard Operating Procedures
• Product Testing and Certificates of Analysis
• Product Inspections
• Corrective Actions
• Process Improvements
As you can see, the use of Documentation extends throughout the manufacturing and quality processes. It is the importance of these two tools that led to the use of the saying within the industry, “If it isn’t written
down, it didn’t happen!” 1
Guidance for Industry: Cosmetic Good Manufacturing Practices, US Food and Drug Administration, June 2013.
Dr. Strand’s Medical Minute #6: Do Your Supplements Dissolve?
As a physician, I originally did not think too much about whether the nutritional supplements my patients were taking actually dissolved or not. All of the drugs I prescribed, whether or not they were brand-name or generic, were required to follow USP (US Pharmacopeia) standards. This means that the quality and dissolution of the tablet were regulated. This is not true for the nutritional supplements industry, as the regulations governing this industry differ from those governing the pharmaceutical industry.
When I was doing research for my book, What Your Doctor Doesn’t Know about Nutritional Medicine [Thomas Nelson, 2002], I found a study done at the University of Maryland. Here, nine different prescription prenatal vitamins were studied. Researchers did not look at what was in the tablet; they simply looked at whether the tablet dissolved or not. To my amazement, only three of the nine prescription prenatal vitamins dissolved. What good does it do to have the right nutrients in the right amounts if your tablet doesn’t even dissolve? You are just wasting money. It is imperative that any supplements you choose to take follow USP guidelines. This is the only way you can be assured that your tablets are dissolving.
When you consider taking prenatal vitamins, remember this study. I did obstetrics for the first 21 years of my practice. I actually used to recommend a brand of supplements called Materna. This prenatal vitamin was produced by a pharmaceutical company called Lederle. The year after I quit doing obstetrics, I read an article that appeared on the front page of USA Today that shared a lawsuit regarding Materna vitamins. The plaintiff in the case was claiming that her child was born with a neural tube defect because the Materna vitamins had been shown not to dissolve. It is well known in the medical literature that any woman who is considering getting pregnant should be taking vitamins, especially 400 to 1,000 mcg of folic acid to decrease the risk of her baby being born with a neural tube defect like spina bifida or hydrocephalus. In this case, this lady was taking Materna before getting pregnant and during her pregnancy, and still had a baby born with a neural tube defect. Again, what good does it do to take vitamins if they do not even dissolve? Therefore, it is critical that you take nutritional supplements that follow USP guidelines.
We are happy to announce that we have new data to report from Sydney University’s Glycemic Index Research Service (SUGiRS) for Moa™ and Moa II. The research performed by the SUGiRS group confirmed the Low Glycemic status of these two products, with Moa yielding a glycemic index score of 52±4, and Moa II yielding a score of 55±5, both of which classify as Low Glycemic.
For those in the Northern Hemisphere, now is a good time to take advantage of the increasing hours of daylight by getting outside and being active. In addition to exercise, this also allows our bodies to produce Vitamin D.
Vitamin D is both a vitamin and a hormone. It’s a vitamin because our bodies cannot absorb calcium without it, and it’s a hormone because our bodies manufacture it in response to our skin’s exposure to sunlight.
In addition to enabling the body to absorb calcium, recent research is revealing additional benefits that Vitamin D brings to the body, such as cancer and type 1 diabetes prevention, so be sure to get your Vitamin D!
ARIIX Quality – R&D Product Testing Part 1 of 3
First, we’d like to introduce you to the newest member of the ARIIX Quality Team, Jason Child, our Quality Inspector. Jason comes to ARIIX with 21 years of manufacturing and quality assurance experience across several industries, including aircraft and automotive components, custom window blinds and dietary supplements. We’re excited to have Jason join our team and use his skills to ensure you receive only the best quality products
Product Quality at the Source Part 1: Product Testing
The Frequently Asked Question we’d like to discuss today is, “How many times does a product get tested before it gets to me?”
Before we answer this question, let’s first explore what product testing means, specifically.
Product testing, as required by the U.S. Food and Drug Administration (FDA) includes testing for four major criteria. These criteria are Identity, Purity, Composition and Strength.
- Identityis the verification through testing that the material is what the vendor says it is (e.g., the powder being sold as Pea Protein is in fact pea protein powder).
- Purityis the verification through testing that the material is free from harmful substances, such as heavy metals, pesticides and harmful microorganisms (e.g., coli, Salmonella or Staphylococcus aureus).
- Compositionis the verification through testing that the material is made up of what it is supposed to be (e.g., powder labeled as Pea Protein does in fact contain pea protein).
- Strengthis the verification through testing that the material meets the potency listed on the label (e.g., Pea Protein labeled as 90% protein is at least 90% protein).
Before each ingredient is shipped to our factories, the ingredient manufacturer must test it to ensure that it meets the established specifications for each of the four testing criteria.
Once the ingredient has passed testing by the ingredient manufacturer, it is shipped to our factory. At the factory, the incoming ingredients are inspected to make sure there are no physical defects and that the material is labeled appropriately and appears correct in terms of color, texture, particle size, aroma and flavor, as applicable (part of Identity verification). Once this inspection is complete, samples of each ingredient are collected and taken to the laboratory for additional testing.
Ingredient testing at the factory is done to confirm the ingredient manufacturer’s testing (as reported on their Certificate of Analysis); consequently, the criteria tested for the ingredient are generally re-tested at the factory to ensure the ingredients are acceptable for use.
After the ingredients have completed testing with favorable results, they are used to manufacture the finished product (more on this process in a future Quality Message).
Once the products are manufactured, they must also be inspected and tested to ensure they meet established specifications for Identity, Purity, Composition and Strength prior to being shipped to ARIIX.
In addition to our manufacturers’ testing of products, we also enlist the help of professional laboratories to test products if we feel additional testing would be beneficial.
ARIIX Quality – R&D Product Testing Part 2 of 3
Product testing is performed using a variety of instruments and traditional chemistry and microbiological techniques. (Photos below courtesy of ARIIX Manufacturer and Microbiological Testing.)
Traditional microbiological testing involves the use of culture tubes, petri plates and culture media. Tests are performed using different culture media, which promote or prevent the growth of the microorganisms in question. For example, in standard testing for Staphylococcus aureus, media containing certain sugar metabolized by Staphylococcus, along with elevated levels of salt, which prevent the growth of other types of bacteria, and a chemical which changes color in the presence of acid (which is produced as the bacteria metabolize the sugars) are used to indicate the presence of S. aureus in a sample.
PETRI PLATES CONTAINING MICROBIOLOGICAL CULTURE MEDIA.
A MICROBIOLOGIST PREPARING SAMPLES BY ADDING DISSOLVED PRODUCT TO PETRI PLATES.
These traditional microbiological tests can take several days, as they rely on the growth of microorganisms into colonies which can be counted visually, which is quite slow. In recent years, instruments which speed up these tests have become more common. These instruments operate on a similar principle — promoting or preventing the growth of microorganisms by culture media — but use special receptacles for the samples and media and sensitive detectors which can measure changes within the culture to calculate the number of microorganisms present.
SAMPLE RECEPTACLE CARDS FOR RAPID TESTING.
RAPID TEST READER INSTRUMENT.
Microbiological analysis seeks to answer two questions: (1) “What kind of microorganisms are present in a sample?” and (2) “How many microorganisms are present in that sample?” Typical microbiological tests include some generic tests, such as:
- Total Plate Count — a measurement of the total bacterial count in a sample.
- Total Yeast & Mold — a measurement of the total fungal count in a sample.
- Total coliforms — a measurement of the total count of bacteria of a family to which several pathogens belong.
Plus specific tests, including targeted screens for pathogenic bacteria:
- Presence of Salmonella
- Presence of Staphylococcus aureus
- Presence of coli
ARIIX maintains strict specifications for our products to ensure they are free from harmful microorganisms.
One method for establishing the identity of herbal ingredients is through Microscopic Analysis. This method requires extensive training and some sophisticated microscope equipment, but it is very useful in verifying the identity of herbal ingredients used in ARIIX products. Our manufacturer is one of the few laboratories in the U.S. to use this method and is recognized as an expert in this field by many in the industry.
ARIIX Quality – R&D Product Testing Part 3 of
ARIIX Chemical Testing
With product testing, traditional chemical tests are often called “wet chemistry” or “benchtop tests,” and often involve using solutions of different chemicals to test products. Common traditional tests include pH (a measure of the acidity of a sample), Titration (adding a chemical to a sample until a color change reaction occurs to measure the quantity of a constituent of the sample, such as vitamin C), Loss on Drying/Moisture Content (measuring the amount of moisture in a sample), Thin Layer Chromatography (measuring a chemical “fingerprint” of a sample to verify Identity) and disintegration time (measuring the amount of time a capsule takes to break down in the stomach).
A THIN LAYER CHROMATOGRAPHY (TLC) PLATE SHOWING AN EXAMPLE OF A TLC CHEMICAL “FINGERPRINT.”
In the last few decades, the use of laboratory instruments to perform chemical analysis has greatly expanded our ability to test materials. Our laboratories (both suppliers’ laboratories and professional contract laboratories) utilize the following instruments:
- Infrared (IR) spectrometer — Measures a “chemical fingerprint” which can be used to verify the Identity of a sample.
- Spectrophotometer — Measures the absorbance of light at different wavelengths; can be used to determine the quantity of vitamins or other compounds within a sample.
- High-Performance Liquid Chromatography (HPLC) — Very sensitive instrument that separates compounds within a sample dissolved in liquid and measures the quantity of desired compounds to verify Strength specifications (e.g., verifying the level of vitamins in a sample). Quantities are measured in the parts per million range.
- Gas Chromatograph — Mass Spectrometer (GC-MS) — an Extremely sensitive instrument which operates similar to HPLC, but uses gas instead of liquid. More than one million times more sensitive than HPLC. Useful for measuring Purity of a sample (such as in verifying that a sample is free from pesticides or other undesired chemicals).
- Inductively-Coupled Plasma — Mass Spectrometer (ICP-MS) — Measures minerals and metals within a sample. Similar sensitivity to that of GC-MS; useful for measuring the Composition (e.g., verifying the quantity of desired minerals in a sample) and Purity (e.g., verifying that a sample does not contain heavy metals) of a sample.
INDUCTIVELY-COUPLED PLASMA — MASS SPECTROMETER (ICP-MS) INSTRUMENT.
HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) INSTRUMENT.
The answer to our question?
An ingredient has tested a minimum of twice before it gets used in product manufacture, and in all, ARIIX it is tested a minimum of three or even four times, with many tests each round, before it gets to you. We take quality THAT seriously!
We hope this information helps you to understand how important Quality is to ARIIX.