Ensuring Quality Crucial to Industry Viability

The issue of quality control (QC) remains one of profoundinterest to industry members. Whether in production, sourcing or claims, qualityis the goal. Natural Products Industry INSIDER asked several leadingindustry executives about their quality control procedures and the majorproblems facing the industry in this field. Here, you'll find their opinions onthe major problems with quality control in the natural products industry.

What are the major problems with qualitycontrol facing the natural products industry?

Stephen Ashmead, director of research & development,Albion Advanced Nutrition: First, there is no independent certification orvalidation of companies' quality control procedures. In the animal feed market,AAFCO sponsors a laboratory testing services. In this service, the lab pays ayearly fee and gets a sample on a monthly basis. The lab does not know what itcontains, but performs its assays and submits back the results. The results fromall laboratories are combined and a report is generated that shows what yourscore is and how you compare to the average and bias of all the otherlaboratories. There is no corresponding service for the natural productsindustry, or even segments of it. This is crucial. The No. 1 reason why thereare inaccurate test results is incorrect analytical technique, followed by poorstandards. A third-party validation such as the AAFCO feed composition programwould expose these problems so they could be corrected. Albion is fortunate inthat we are aware of these programs due to our other divisions, and canparticipate and extend this to our human manufacturing division.

Second, there is a lack of acceptable and universal standards.For a pH test, recognizable standards can be bought from reputable chemicalsupply houses, and very few people doubt the veracity of that standard. The samecan be held for metal standards for ICP, ICP/MS, AA, etc. However, suppose thatyou want a standard for a botanical. Where do you get it? Generally, you mustmake your own, and then how do you validate that you have extracted all of theactive ingredient to serve as the standard?

Third, there is no recognized independent industry"watchdog" for label claims. Recently, ConsumerLab.com put on its Website the report of its magnesium study. It lists the magnesium source, but onlytested for magnesium content. It did not test for the various forms of magnesiumlisted on the label. Generally, organics are higher in price than inorganics,but do you know if the product that you purchased really has magnesium citrate,or is it magnesium oxide? In my opinion, ConsumerLab.com and similar testingservices are doing a disservice to the industry without that additionalinformation. It is also promoting the cheating of manufacturers to make labelclaims at all costs.

Finally, there is no verification of quality in conjunction withGMP. Until quality and GMP are tied together, any GMP-certifying agency forfinished goods will only promote a false sense of quality and will be used assuch. ConsumerLab.com is predominantly quality, but not GMP. NNFA ispredominantly GMP (procedures), but not quality. The two aspects need to be tiedtogether.

Todd Norton, president, Sabinsa Corp.: One--the lack ofgenerally accepted assay methods and reporting of active ingredient percentages.There is a significant problem in this industry with companies buyingingredients and relying solely on what is reported on the product certificate ofanalysis to assure quality. Some ingredients report an assay based on HPLC, andothers report it based on UV or gravimetric or something else. Either way, theresults are bound to differ. Take guggul extract, for example. Sabinsa offers aminimum 2.5 percent Guggulsterone Z&E content in our Gugulipid product, asshown in clinical studies to be responsible for therapeutic benefits. We measureour guggulsterone content by HPLC to be precise. We compete against othergeneric guggul extracts that claim to offer 10 percent guggulsterones, yet whenpressed on the method of analysis used to determine this percentage, the answeris either by UV, or "I don't know." So, what levels of guggulsteroneZ&E do they really contain? And what is it exactly that constitutes the 10percent assay? Now let's fast forward to the retail shelf. If two guggulproducts are side by side and one claims 10 percent while the other claims 2.5percent guggulsterones, assuming they are similarly priced, which one will theconsumer likely buy? Some manufacturers, when seeking the higher potency listedon a competitor's label then feel compelled to modify their product also. Doesanybody along the way ask the question whether the jump to a higher assay ispractical, necessary or possible in the first place? Sadly, the matter is bestsummed up by a comment made by industry consultant Jay Jacobowitz: "It'sremarkable that in our industry it is 'news' when potency matches labelclaims."

Two--the lack of substantiated agreement on what actives areresponsible and in what percentages for certain health benefits in botanicals.Look no further than to the media-beating this industry took over St. John'swort not long ago. After all, as long as it's St. John's wort, it's all thesame, isn't it?

And third--too much downward pressure on pricing. I am a firmbeliever that in most instances you get what you pay for. The trend towardconstantly chasing the lowest price is taking an adverse toll on productquality. What is basically happening is the barriers to entry to be a supplierof ingredients keep getting lowered, yet industry manufacturers increasinglyexpect suppliers to provide more documentation, product testing and marketingsupport. This is an inverse relationship, and it only can last for so longbefore something gives.

My father worked in the poultry industry for nearly 20 years.His company adopted the following motto and I think it is appropriate: "Thebitterness of poor quality will remain long after the sweetness of low price isforgotten." Sound words of wisdom for any industry, especially oneprofessing to transform the "snake oil" persona that shows uprepeatedly in the mass media. Quality, or the lack thereof, does come with aprice. It is up to the industry to decide where they will pay.

David Parish, president and chief executive officer, DesignedNutritional Products: I have heard that some companies are willing togenerate a certificate of analysis that says whatever the customer needs it tosay. This is a deplorable practice and can severely damage an industry alreadyunder scrutiny. Companies should be careful not to place too much confidence ina piece of paper until the results can be verified. Furthermore, inability orunwillingness to provide analytical procedures for review should also raiseconcern.

As someone cross-trained in certain analytical methods, I seeanother problem associated with creating test methods that generate meaningfuldata. Even when meaningful data can be obtained, accurate interpretation of thisdata is also essential. An HPLC assay can report a purity of 101 percent, butwhat does this really mean? Many people assume that HPLC purity of 99.9 percentcan be taken at face value. They fail to realize that HPLC can make garbage lookclean if the method is not carefully developed or the standard is not pure. Ihave seen this both as a result of incompetence and as a deliberate wanton act.

Lastly, possibly the biggest threat to overall quality controlis the failure of businesses to totally embrace true quality concepts. Companiescan achieve quality registration by going through the necessary steps but stillfall short of complete conversion. The sole purpose of quality concepts shouldbe to improve how the final consumer is served. This automatically implies manyother benefits, such as lower costs, higher production, faster delivery, abroader customer base, less liability and increased profits. Getting qualitycertification solely for the perceived marketing value is largely a waste ofmoney and can potentially cost dearly.

Robin Ward, marketing manager, Linnea: First, the focuson price rather than the quality of ingredients. There is currently noobligation in the United States to test raw materials; the certificate ofanalysis provided with an ingredient is considered sufficient under currentlegislation. No re-testing is currently required, nor is proof that the productwas manufactured under validated GMPs or that the product was tested by acompetent and validated laboratory.

Second, testing for what should not be in the product is asimportant as testing for an active ingredient. The current focus of testingseems to be on the active or marker ingredient. Testing of identity,quantitative and qualitative composition, as well as residual solvents,impurities and microbiological content, should form part of the quality controlfunction. Again, the focus on price and not quality of an ingredient is abarrier.

Finally, the lack of uniform industry standards for the testingof materials. The ongoing work of organizations like the U.S. Pharmacopoeia andNSF is critical in this regard.

Greg St. Clair, vice president, Arizona Nutritional Supplements: 1) Lack of standards for raw material suppliers; 2) Lack of enforceablestandards from industry governing bodies; 3) Lack of support from industry/trade individuals and companies.

Walt Jones, president, Caraloe Inc: Identification of actives and the methods used toidentify. The testing methods we have developed for our natural products are thesame testing methods we developed for pharmaceutical. It is critical that asnatural products, we establish base quality standards for identification andalso some type of quality standards for our products.

What types of QC certifications do you hold?

Ashmead: We currently do not have any third party certifications. Weare preparing for ISO certification and training our personnel for ASQcertification. Until those certifications are in place, we allow our customersto audit our facilities upon request. Our GMP procedures are a hybrid synthesisof proposed FDA dietary supplement GMPs, NNFA GMPs and customer requirements.

Jones: We hold ISO 9001/2000,cGMP for drugs and certification for organic raw material.

Norton: Sabinsa is the sales and marketing arm for our manufacturingoperation SAMI Labs Inc., which is located outside the United States. SAMI Labsrecently obtained World Health Organization (WHO) certification for itsmanufacturing operations.

Parish: Designed Nutritional is ISO 9001:2000 registered. GMP isthe next quality certification we will attain.

St. Clair: We hold two GMPcertifications. One is through the NNFA and the other is through NSF.

Ward: Linnea adheres to pharmaceutical standard quality assurancesystems combined with strict pharmaceutical GMP compliance. Our operations areaudited and validated by the IKS, the Swiss version of the FDA, which issues ourGMP certification. Pharmaceutical GMP is the top level of certification.

How did you determine whether to hold a QC certification,and what does it offer you and your customers in the marketplace?

Ashmead: The determination is based upon what will serve the majorityof our customers, the reputation of the certifying agency and availableresources. In my opinion, the current dietary supplement certifying agenciesonly offer a marketing advantage. They do not offer any assurances to thecustomer that the manufacturer is not cheating on the supplement, only that themanufacturer is following a set of procedures all the time. It could be saidthat they only offer a false sense of quality to the customer.

Jones: We manufacture wound care products that are prescription drug and 510kproducts so we are mandated to use cGMP by FDA. ISO 9001 certification allowsour products to carry the CE mark for importation into Europe and othercountries throughout the world.

Norton: Sabinsa has a number of agents worldwide that represent ourproduct line, many of which are affiliated with the European Union. We felt thatWHO certification would best serve our diverse customer base and be universallyrecognized in the major international markets where we have a presence.

Parish: Many people misunderstand the purpose and utility of ISOregistration. ISO is NOT just saying what you do, doing what you say, anddocumenting everything. When applied properly, ISO is a powerful business toolthat eliminates scrap, increases production, improves efficiencies, decreasescosts, establishes accountability, and delivers more value to thecustomer. All this makes it easier to compete in the marketplace. Weselected ISO for the value it brought to our business systems and overallcustomer satisfaction. Creating barriers to competition is just frosting onthe cake. We find that prospects place more confidence in a company willingto adhere to this international standard.

St. Clair: Our volunteering to become GMP certified was a natural progression toour companys growth. We also feel that we must continue to strive for betterstandards and continue to support our industry. We also work hard to providequality and assurance through our commitment with the certification programsthat ultimately provide efficacy and safety in our products.

Ward: We sell extensively to the pharmaceutical as well as the dietarysupplement and cosmetic industries; therefore pharmaceutical GMP certificationis a prerequisite. The same exacting standard is applied to the manufacture ofall our products whether for the pharmaceutical, dietary supplement or cosmeticindustries. Our manufacturing philosophy is based on three pillars--safety,quality and consistency. To this end we invest extensively in manufacturingtechnology, in-process control and quality assurance. This includes developmentof fully validated manufacturing process, fully validated analytical methodologyand fully validated operating procedures (SOP's). The Linnea label stands forpeace of mind and due diligence; effectively we build in the safety, quality andconsistency. Many manufacturers of dietary supplements prefer to deal directlywith a manufacturer than sourcing anonymously through trading companies. Theclich it is not quality that costs but a lack of quality is verypertinent in our industry. Our consistency of product is reflected in ourcustomers product. It provides an assurance of the same quality each andevery time. This is very important for our customers when building brand loyaltywith the consumer. Our attention to detail also protects our customersbrands. From a purely manufacturing perspective a lack of quality and productconsistency can also generate expensive delays in tablet or capsulemanufacturing, unacceptable variability in the quality of the finished productor even complete rejection of batches.

What do you do to ensure the quality of the raw materialsyou supply?

Ashmead: Since we are a manufacturer, each raw ingredient is certifiedas acceptable before it is used in production. It is tested for the requisiteparameters when it is received and when it passes the QC specifications, it isreleased to production. After the production process, the finished product istested for the parameters specific to the product. The product must pass allspecifications before it is released. All tests are conducted by in-housepersonnel and equipment, with the exception of microbiological assays. Those aresent to a state certified microbiological laboratory.

Jones: All of our raw materials we supply are strictly tested and validatedjust as if they were pharmaceutical products. Very tight specifications andstandards are used to ensure the quality and identification of each item andcomponent.

Norton: People need to remember that we are dealing with plantproducts that can, and do, change depending on which region they come from andthe season in which the are harvested. The Sabinsa/SAMI operation is 100 percentvertically integrated. In some instances we control the cultivation of certainbotanicals, and go so far as to provide our farmers with the seedling plants toensure the right species is grown. When purchasing raw materials from outsidesources, such as small villages or collection groups, we have a procurement teamthat travels with a portable testing equipment to quickly assess the identityand potency. If further testing is required we send the materials to ourlab in the corporate office. Based on these results we either purchase orwe dont.

Parish: Product specifications are established for every product webuy and sell. Even if we provide a supplier with the testing procedure forproduct verification, we verify the product specifications through third partyindependent analysis. Knowledge of the product and potential problems specificto a given product, enable us to look for the right things in the right places.SOPs for equipment cleaning and product handling minimize the likelihood ofcross contamination in house. 

St. Clair: We have several standard operating procedures (SOPs), from receiving ofmaterial to the shipment of finished products that identifies and ensuresquality. We also have 20 percent of our staff dedicated to QC throughout theproduction process and our on site laboratory gives us flexibility oftime. 

Ward: Strict raw herb sourcing is vital to ensure the efficacy andsafety of an herbal extract. Both the pharmacological activity and the safetyprofile of an extract are species- and genus-specific. Also, botanical speciesthat appear very similar may have vastly different compositions; a healing herband a toxic plant can easily be confused by the inexperienced eye or carelesshand. To insure raw herb integrity and complete supply-chain traceability, wenever source raw materials through anonymous trading companies; instead, our rawmaterial procurement specialists rely on their expertise, long-standingrelationships with key suppliers, and the raw materials that we grow on our ownplantations around the world. Once raw materials arrive at our plant forextraction, they are subjected to further testing (sight, smell, and taste) forspecies classification before their final chemical analysis in our QualityAssurance laboratories. We also test extensively for pesticide and herbicideresidues in our raw materials and finished extracts to insure safety fromadulterating and/or potentially harmful substances. Because much of the natureand activity of many botanicals remains undefined, we go further than the basicstandardization of extracts. We believe it is important that botanical extractscontain not only the key ingredients and markers, but also the broad range ofingredients characteristic of herb, the unknowns and synergistic compounds vitalto the true nature and activity of the herb. Linneas extracts are clearlyidentifiable from their HPLC fingerprints. This uncompromising approachalong with our validated GMP manufacturing process ensures the safety, qualityand consistency of the botanical extracts we manufacture. 

What types of tests do you conduct on raw materials, andhow do you determine the testing methods used?

Ashmead: Our tests include physical examinations, metal content, heavymetal content, identity testing, Kosher certification and other tests to thespecification of the ingredient. The methods that we use are published methodssuch as AOAC, USP, USEPA, etc., that are modified for our specific equipmentsetup, i.e., Agilent vs. Perkin Elmer.

Jones: Besides the typical HPLC, we also do light refraction, microbiologicaland comparison to standards.

Norton: The first thing to do is confirm with an identity test,usually thin layer chromatography (TLC), that you have the correct species ofplant. Once confirmed, and before production begins on any of our standardizedextracts, we first determine the assay value of our starting material. From herewe can determine if any modifications are required to our manufacturing process.The whole idea of a standardized botanical extract is to provide the samepercentage of active constituents from batch to batch. Testing the finishedmaterial varies depending on what the product is standardized for. Whereverpossible an HPLC method of analysis is recommended due to the high degree ofaccuracy and reproducibility it offers. This is a good method to use when youwant to identify a specific compound. Some products, however, contain amixture of compounds that provide the activity. The methods generally used fortesting in these instances are UV spectrophotometry or gravimetric. Thesemethods identify compounds that are similar in chemical structure, therebygiving a cumulative percentage of their presence in the material. Themethodology used is a function what you are testing for in the product. Thereare also other sophisticated methods and equipment available that can test forthings like residual solvents and pesticide levels.

Parish: Designed Nutritional utilizes published standards of analysisfor many compounds. These include IR, HPLC, GC, size exclusionchromatography, X-ray fluorescence, mass spec, NMR, melting point, solubility,titration, microbiological, elemental and heavy metals analysis. Occasionallyanalytical methods need to be developed for specific purposes. Steps aretaken to validate both the methodology and the results. Deciding on whichtesting to conduct largely depends on the nature of the product, our knowledgeof the processing, and the needs of the customer. 

St. Clair: Our testing on raw materials is accomplished through several methods(i.e., F.T.I.R.spectrometer and soon our in house H.P.L.C.). These methodsprovide identification, separation, purification and quantification.

Ward: All Linnea extracts are subjected to extensive testing by ourQuality Control laboratories, which employ such analytical capabilities as HPLC,TLC, HPLC mass detection, photometric and colormetric assay. The analysis of rawmaterials normally requires that two key criteria are met. Product identity, oris the product what you think it is? Not to be confused with testing for astandardized marker or active ingredient as products can be spiked, thushiding their true identity. An identity test confirms the origin of the extractand/or gives a qualitative profile of the key compounds. Quantitative analysisensures the key compounds are within the specified upper and lower limits. Inthe case of bilberry we test for identity by TLC, qualitative analysis is madefor profiling of the anthocyanosides by HPLC and the quantitative analysis ismade by colourmetric assay. It is also important to analyze for what should notbe in the product, including testing to confirm the required low levels ofresidual solvents, low levels of heavy metals, low or absence of impurities andpharmaceutical standard of microbiological control. At Linnea we also test toensure consistency of the physical aspects of the product including bulk densitytesting and laser particle size analysis. All methodology and instrumentationshould be validated in accordance with international protocols. The type ofanalytical method chosen depends on the nature of ingredient and its chemicalscomposition. Certain ingredients are better suited to analysis by one type ofanalysis than another. In some case we use the published methods, such as thosethat appear in Pharmacopoeias, monographs or other peer reviewed sources. Inother cases, the methods have been developed and validated by our ownlaboratories.