Journal of ARIIX Quality Vol 2 No 3, March 2019
For the past two messages, we’ve discussed 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 was regulated. This is not true for the nutritional supplements industry, as the regulations governing this industry differ from those governing the pharmaceuticals 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!
Below are a few articles addressing these findings:
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