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Natural Product
Quality Assurance, Who cares? Natural
Product Quality Assurance, Who cares? Natural product manufacturing companies ask you to trust their quality. They believe that the raw materials purchased from their suppliers are tested in some manner and are therefore authentic. However, most natural product manufacturing companies do no testing whatsoever and rely solely on the certificate of analysis provided to them by their raw material supplier. A significant number, if no a majority of raw material suppliers and nutritional supplement manufacturers do no independent or in house testing for confirmation of their raw materials or finished products. There currently is no oversight body that makes sure natural product companies comply with either the already in place FDA Food GMPs (Good Manufacturing Practices) or the proposed FDA GMPs for nutritional supplements (sooner or later the government is going to step in and regulate the industry). Trust in not enough to rely on. The industry is not trustworthy. The chain of events needed to produce quality natural products is too long to "trust" it will happen with consistent integrity. A standard already exists (proposed FDA GMPs for nutritional supplements). Now is the time to hold suppliers accountable to follow those standards only. Everybody must follow the same map. Otherwise we again have inconsistency and some level of chaos. As an example, one popular professional products company has recently advertised that they have developed a new "gold standard" for testing product quality. They are going to test finished product only vs. the "old" method of testing raw material when it comes in. This is an untrue (as it is not a new gold standard) and ridiculous assertion (for many reasons), but the uneducated professional will probably believe it. I and my practitioner colleagues have "assumed" and "trusted" that our suppliers were performing the due diligence and quality assurance necessary to produce consistent high quality product. We have been duped for years. Until the government steps in it is up to the individual practitioner, store, or clinic to educate themselves about quality manufacturing guidelines and hold their individual suppliers accountable for following those guidelines. The goal is to choose natural product suppliers that produce a uniform, high quality, consistent, pure, good finished product according to an already established and accepted guideline. This helps obtain a higher clinical response and minimizes treatment failure that may be due to poor, inconsistent quality. The tools - This information will give you an understanding of how to evaluate and audit the level of "manufacturing and product quality assurance" achieved by natural product suppliers. I describe and give detail of the most important pieces; raw material testing, testing methodology, GMP guidelines, operating according to SOP's (standard operating procedures), internal auditing and quality assurance, finished product testing, sample retention, stability testing to establish an expiration date, and third party certification of quality assurance. Once you have read this information you will have some understanding of quality assurance. Ask questions of your suppliers but don't stop with their answers. They are just words. Ask for and require proof. Hold them accountable. Who manufactures the Products? This is very important to know because it can affect many aspects of manufacturing and finished product quality. Scenario #1 - The Company manufactures its own products. This is the preferred option. Raw material selection, testing, and production can be done directly by the company and should take place in a clean, strictly controlled environment that they monitor and adjust as needed. In this scenario, precisely what goes into the product (with adequate documentation as proof) and most importantly what is NOT in the product. Scenario #2 - The company sources, purchases and tests the raw material and then sends it to an outside manufacturer to produce the tablets or capsules. Quality can be monitored very closely in this case because the only job the outside contractor is performing is the production of the table to capsule. Scenario #3 - Finally, many companies have the product produced by an outside party called a contract manufacturer. Here the company depends entirely on the outside manufacturer and has little or no control of materials selection, testing, quality control or the manufacturing process. A much higher degree of due diligence is required here because the company selling the product has a harder time of assuring quality of raw material, testing, and manufacturing unless they take a very active role and set quality bench marks and audits for the contract manufacturer. Allowing the contract manufacturer to make those choices on behalf of the company can be deleterious to quality. Good quality can be obtained in scenario 2 or 3, but the company hiring an outside manufacturer needs to personally inspect and audit the plant and manufacturing process. The company also gives the manufacturer strict criteria on material procurement and what testing is required to assure quality. Once that has been established, some paper trail is provided to the company to prove that the manufacturer has met their stipulations. Many companies that hire an outside manufacturer do not perform the due diligence required to assure overall product quality. Quality Assurance Issues
Raw Materials Sourcing Ask the company to answer the following questions about their criteria for purchasing raw material. Frequently, sales reps do not know this information. If you really want to know you may have to press them for it. Raw materials can be purchased from a broker, distributor, directly from the manufacturer, domestically or abroad. In any case asking to see if the company answers these questions helps steer you toward getting a quality product and weeds out the underperformers.
If it is herbal material, ask the following questions in addition to some or all of the above.
Raw Material Microbiology Testing How does the company ensure the raw material is clean? Was it tested and found free of bacteria, mold, and yeasts? At the very least, companies should test each lot of incoming material and comply with USP/NF #23 1995 MICROBIAL LIMITS (Page 2129) which are as follows: The total aerobic bacterial count does not exceed 3000 per gram, and the combined yeast and mold counts do not exceed 300 per gram. Material must also meet the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus. Raw Material Verification Assay How does the company ensure the raw material is authentic? Once a raw material is received, it should be quarantined. From there it should be sampled and tested for bacterial and mold contamination. In addition, the supplier's material should be verified. This is done by identifying and assaying the material by an inside or outside lab for authenticity and potency. The lab verification should be done on the first 5-10 batches used for production and if it meets the required specifications, further assay verification need only take place 2-3 times a year to make sure there have been no changes in quality. This is called skip lot testing. However, from that point on each lot of raw material purchased needs to be laboratory identified (ID) vs. assayed in some manner to make sure it is in fact what was requested. In addition to the independent assays and ID testing the supplying vendor should be audited by the purchasing company as an extra measure of ensuring quality assurance. If a vendor is dropped and a new vendor is used the same verification schedule should be followed. In some cases the product should be tested for any toxic metal or assay for authenticity criteria, it should be rejected and sent back to the manufacturer. Only raw materials that pass get released from quarantine and used for production. Much of the raw material used in the production of nutritional supplements is purchased from distributors or brokers that buy large quantities of a product and repackage it for distributions. Many of these vendors do not test for authenticity or do microbiology testing but rely on the manufacturer to do that and accept at face value the certificate of analysis provided by the manufacturer. Whenever a product gets repackaged it has the potential to be contaminated or adulterated. The natural product manufacturer must verify that this has not happened by doing the testing themselves. By doing so you are simultaneously checking the distributor and the original manufacturer. The results of raw material or finished product testing is only as good as the lab used, the method being used and the standard used to compare the sample against. Unfortunately, the lab industry is as unregulated as the natural products industry. A lab method can be made up or changed by the lab to get the results they or the company who sent the sample wants. In addition, the standard can also be inappropriate. In the lab industry, there is a concept known as "validation". Ideally a lab would only use a method and standard that has been validated. Validation is a process of testing and resting a method or standard so the bugs get worked out and it can be used repeatedly with a predictable level of accuracy and precision. Validated methods exist for most vitamins, minerals, and trace metals. Validated methods and standards exist for some botanicals and many still need to be developed. The pearl here is that if a company claims to test their products, ask if the lab they use has been audited by them or an independent agency for GLP's (good laboratory practices). Ask if they use lab test methods and standards that have been validated. Otherwise, they might be using jury-rigged methods that skew the results in the direction of what they want to see vs. what they really are. Rancidity Testing of Oil Soft Gels Lipid soft gel products can become rancid due to exposure of the oil to heat, light, or oxygen before or during the softgel encapsulation process. Peroxide value is a measurement of peroxides (free radicals) in an oil product and anisidine levels measure aldehydes, peroxide levels and anisidine levels together make up a total oxidation value for an edible oil. The WHO has established an acceptable upper level limit of 10 meq/kg for peroxide value. Any product that exceeds 1- meq/kg is not fit for consumption. A level of 0-5 is ideal, 6-7 marginal, and above that probably unacceptable. Lipid softget products should be independently tested for peroxides and anisidine levels to ensure a low level of rancidity. Heavy Metal Testing Select raw materials should probably be tested for the presence of lead, mercury, cadmium and arsenic. In 1997 the California department of Health tested 260 Chinese patent medicines for lead, mercury, arsenic, drugs, and chemicals. They published the results and called it the Compendium of Asian Patent Medicines. Many products were found to contain drug and chemicals but most alarming was the number of products contaminated with toxic metals. Forty-two (42) products contained arsenic, two hundred and fourteen (214) products contained lead and forty-two (42) products contained mercury. According to the US Pharmacopoeia, oral products that contain more than 10ppm of lead, 3ppm of arsenic and mercury are considered unsafe. While not all of the products that contained heavy metals exceeded this standard, it would seem that any level when used long term or repeatedly is unsafe. Lead varied from 0ppm to 184 ppm, Mercury from 0ppm to 5070ppm, and arsenic 0ppm to 114,000ppm. It would seem prudent that Chinese herbs be tested for toxic metals to ensure their freedom from toxic metals. Manufacturing Ideally a natural products company would comply at least with the United States Pharmacopoeia, FDA food GMPs or NNFA GMP guidelines for all of the production procedures done in the facility. The USP23 (United States Pharmacopeia pages 2180-2192) and the Federal Register (Volume 62, no. 25., pages 5700-5709) have published guidelines for the following: receiving, quarantine procedures, microbiological testing, authenticity and potency testing, ID testing, release for production criteria, batch production and recording data, finished product verification, production cleanliness, finished product sample retention, lot number/customer retrieval database systems in case of a need for product recall and recommendations for SOP's (standard operating procedures). Unfortunately, some of these guidelines are not thoroughly outlined and are left to interpretation. In addition, the guidelines that are in existence are not enforced by any oversight body leaving manufacturer of natural products the freedom to do as they please with no accountability. Ask the company if they adhere to the USP Nutritional Supplement manufacturing guidelines or do they follow the FDA Good Manufacturing Practices (GMP's) for foods. If they follow neither, proceed with caution. Key Point - Have they been audited by an independent auditor to assure compliance with GMP's? Ideally they would have been. It is the only way to get an unbiased verification of their procedures. Label Management and Reconciliation Do they have a program? Is it followed? Wrong labeling of product is a big area for error. Finished Product Testing How does the practitioner know if the amount listed on the label is in the capsule or tablet? A manufacturing company should establish and comply with some finished product assay criteria. This is used to verify that production procedures are actually getting into the capsule or tablet the amount claimed on the label. Each product lot should be assayed to see if it meets label claim. One or more composite samples of 10 randomly selected capsules should be sent out for independent assay to check the amount in it. If the result is outside of the FDA mandated 100% of label claim, production procedures need to be re-evaluated and changed to meet the standard. This is an essential step, especially for products with multiple items. How do you know production is evenly distributing the raw material so the final product is within the FDA specifications? The only way to ensure this is to know that the company is doing some sort of finished product assays on a regular basis. Expiration Dating The purpose of an expiration date is to let the consumer know that the product will stay at 100% of the label claim for the life of the expiration date. The FDA requires that if an expiration date is used, it be established and based upon multiple stability assay tests performed on several lots of finished product over the course of time to actually verify if the potency meets label expiration dates, i.e. they are based on no stability data what so ever. Sample Retention A sample from each finished goods lot needs to be set aside and stored for at least 3 years beyond the date of manufacture. It is used for testing and examination should there ever be a problem with that particular lot. Lot Tracking System A system needs to be in place to track any lot number should there be a complaint that requires a product recall. Vendor audits Each vendor that supplies materials should be audited by the manufacturing company to assure that they comply with a specified quality standard. When the natural products industry was smaller and less noticeable, it could get away with having a broad range of product quality and a "laissez faire" attitude towards the outrageous medical claims some of the suppliers made. Those days are gone. The products we use every day are being scrutinized by the medical community, the media, and the government. The industry is not performing well in this environment. There are too many mislabeled and poor quality products making unsupported medical claims. Our credibility as practitioners with the all-important patient and consumer is at stake. It is time to act. Use this information to hold suppliers accountable for their quality or lack thereof.
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Vital Nutrients 45 Kenneth Dooley Drive Middletown, CT 06457
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