Food Safety Magazine, February/March 2013

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INGREDIENTSBy Rupa Das, M.Sc.Quality Control of Botanical IngredientsPartnerships with dependable, qualityconscioussuppliers are key to a manufacturer’sreputation and success.As the nutrition science industry grows, sodo the questions and concerns regarding quality.Most, if not all, quality-related questionscan be answered by evaluating the cultivationand harvesting practices, the manufacturingpractices and the quality control program adoptedby the ingredient suppliers.One of the challenges the industry faces today is the lackof standardized methods for product assessment. Using differentmethodologies produces different test results. Therefore,a product that may meet all the requirements using a certainmethod may not meet the requirements using a different method.Several industry organizations are currently working towardstandardization of processing and testing methodologies.Manufacturing PracticesManufacturing processes affect the quality of herbal ingredients.Cross-contamination with other products, environmentalcontamination, mix-ups and mislabeling can lead to poorqualitymaterial. These can be avoided by implementing GoodManufacturing Practices (GMPs). Quality-conscious ingredientStandardizedmethods forbotanicalingredient safetyare urgently neededsuppliers have adopted some form of GMPs,whether the product is a drug, a food, a proposeddietary supplement or a combinationof the three. Manufacturers also must contendwith the challenge that ingredients are sourcedfrom diverse geographic locations. Althoughmost of these locations have some form ofGMPs, the standards and enforcement arenot the same as those in the manufacturer’shome market. It is therefore important to check and evaluatethe manufacturing practices of suppliers to ensure high-qualitybotanical products.Ingredient SpecificationsA quality botanical ingredient is one that uses the correctplant species and plant part, is unadulterated, safe for humanconsumption and has the potency (level of chemical constituents)it claims.Different types of identification methods, such as macroscopic,microscopic, organoleptic, thin-layer chromatography(TLC), high-pressure (HP) TLC, HP liquid chromatography(HPLC) and Fourier transform infrared spectroscopy, may beused to identify the genus, species and plant part. Each of theseidentity tests has advantages and limitations. At the very least,54 F o o d S a f e t y M a g a z i n e
INGREDIENTSthe type of identification method(s) used should be specificenough to differentiate between species and plant parts. Inmost cases, different methods must be combined to identifythe plant species and plant part beyond a reasonable doubt.Other than identity, botanicals should be tested for adulterantssuch as heavy metals, pesticides and ethylene oxideresidues. Most countries have regulatory guidelines related toadulterants, and products must meet these guidelines.Aflatoxin and microbiological testing are required to ensurethe product is free of pathogenic bacteria and is safe for humanconsumption. Raw ingredients usually have a high microbialIngredient Supplier SelectionA key step in ensuring the quality of finished products ischoosing an ingredient supplier that will provide material thatmeets all of the requirements. The vendor should be providedwith the detailed ingredient specification—which should bepart of the contract with the customer—so that they can fullyunderstand the customer’s requirements. The supplier shouldreview the specification thoroughly and provide feedback to thecustomer in the form of comments or ask for further clarification.The customer and supplier should agree on the ingredientspecification before placing or accepting orders.“A quality botanical ingredient is one that uses the correct plant speciesand plant part, is unadulterated, safe for human consumption and hasthe potency...it claims.”load and thus require some form of sanitization. Several sanitizationoptions are available, but it is important to understandthe regulatory and quality impact of such sanitization processesbefore choosing one that is appropriate for the specific product.Chemical tests are required to confirm that the materialmeets the claimed potency of active or marker chemical constituents.Depending on the constituent, different instrumentalmethodologies, such as HPLC, gas chromatography or ultravioletspectrophotometry, may be used to quantify these chemicalconstituents.One of the very first things needed to ensure the quality ofbotanicals is to create an ingredient specification sheet detailingidentity (genus, species, plant part), physical (appearance,particle size, density), chemical (chemical constituents, markercompounds), heavy metal, pesticide and microbiological requirementsas well as the preferred sterilization process. Sinceusing different methods could lead to different test results, it isimportant to identify the sterilization and test method on thespecification sheet.In the case of botanical extracts, the ingredient specificationshould also list the raw herb-to-extract ratio, extraction solventsused and any excipients and/or carriers that may have beenused in the production of the herbal extracts.Certificate of Analysis (COA)The ingredient supplier should provide a COA with all shipments.The results of identity, physical, chemical, heavy metaland pesticide residues testing as well as microbiological testingresults should be listed on the COA along with the specificationsand methods of analysis. The COA should be a guaranteethat the product is what it claims to be, is unadulterated and issafe for human consumption. However, the COA provided bythe ingredient supplier should be verified and the test methodsused should be evaluated. It is important for suppliers and customersto agree on test methodologies prior to accepting COAresults.It is very important to review and evaluate the vendor’s capabilitiesand expertise. Some areas that need to be evaluatedare the vendor’s quality unit, including but not limited to theeducation, training and experience of the quality unit staff.The vendor’s Standard Operating Procedure programs, testingcapabilities (including certification of any third-party testinglabs used), laboratory equipment, sanitation programs, processcontrol and pest control programs are some of the areas thatshould be evaluated. It is necessary to assess whether the vendorfollows some form of GMPs and Good Laboratory Practicesin terms of product and document traceability. A site visitand audit of the vendor facility provide critical informationregarding vendor quality.Since the ingredient supplier receives material from diversegeographic regions, a vendor qualification program is essentialto have in place to ensure the quality of raw botanicalsreceived.ConclusionsIt is essential to partner with vendors that understand yourquality requirements and are capable of meeting them. It isonly through this partnership that we can provide high-qualityfinished products to consumers.•Rupa Das, M.Sc., is vice president of global quality and compliance forBI Nutraceuticals. She has more than 20 years of quality and regulatory compliancemanagement experience in the dietary supplement and personal care productindustries. She is a certified GMP auditor and Safe Quality <strong>Food</strong>s (SQF) practitioner.She is involved at different levels with leading industry organizations. Prior to herwork in the industry, she was a chemistry lecturer at several California State Universitybranches.To read more about ingredient safety,please visitwww.foodsafetymagazine.com/signature-series/.F e b r u a r y • M a r c h 2 0 1 3 55
Page 4 and 5: February/March 2013Vol. 19, No. 1FE
Page 6: Editor’s LetterWe at Food Safety
Page 10 and 11: USDA Seeks Comments on ProposedFroz
Page 12: TestingBy Katerina Mastovska, Ph.D.
Page 15 and 16: Testingheat treatment, the toxins c
Page 17 and 18: staying connectedto your data hasne
Page 19 and 20: PROCESS CONTROL1. Scope2. Normative
Page 21 and 22: SANITATIONapproach, 1, 2 while effe
Page 23 and 24: SANITATIONis a matter of legal liab
Page 25 and 26: Accreditationment undertaken by the
Page 27 and 28: AccreditationFood Microbiological L
Page 29 and 30: MANAGEMENTcertain spices. As no acc
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Page 48 and 49: Animals versus PlantsBefore discuss
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Page 56 and 57: SEAFOODBy Gary P. Richards, Ph.D.,
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Food Safety Magazine, February/March 2013

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