Quality Control of Botanical Ingredients
By Rupa Das, M.Sc.
Partnerships with dependable, quality-conscious suppliers are key to a manufacturer’s reputation and success.
As the nutrition science industry grows, so do the questions and concerns regarding quality. Most, if not all, quality-related questions can be answered by evaluating the cultivation and harvesting practices, the manufacturing practices and the quality control program adopted by the ingredient suppliers.
One of the challenges the industry faces today is the lack of standardized methods for product assessment. Using different methodologies produces different test results. Therefore, a product that may meet all the requirements using a certain method may not meet the requirements using a different method. Several industry organizations are currently working toward standardization of processing and testing methodologies.
Manufacturing processes affect the quality of herbal ingredients. Cross-contamination with other products, environmental contamination, mix-ups and mislabeling can lead to poor-quality material. These can be avoided by implementing Good Manufacturing Practices (GMPs). Quality-conscious ingredient suppliers have adopted some form of GMPs, whether the product is a drug, a food, a proposed dietary supplement or a combination of the three. Manufacturers also must contend with the challenge that ingredients are sourced from diverse geographic locations. Although most of these locations have some form of GMPs, the standards and enforcement are not the same as those in the manufacturer’s home market. It is therefore important to check and evaluate the manufacturing practices of suppliers to ensure high-quality botanical products.
A quality botanical ingredient is one that uses the correct plant species and plant part, is unadulterated, safe for human consumption 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 be used to identify the genus, species and plant part. Each of these identity tests has advantages and limitations. At the very least, the type of identification method(s) used should be specific enough to differentiate between species and plant parts. In most cases, different methods must be combined to identify the plant species and plant part beyond a reasonable doubt.
Other than identity, botanicals should be tested for adulterants such as heavy metals, pesticides and ethylene oxide residues. Most countries have regulatory guidelines related to adulterants, and products must meet these guidelines.
Aflatoxin and microbiological testing are required to ensure the product is free of pathogenic bacteria and is safe for human consumption. Raw ingredients usually have a high microbial load and thus require some form of sanitization. Several sanitization options are available, but it is important to understand the regulatory and quality impact of such sanitization processes before choosing one that is appropriate for the specific product.
Chemical tests are required to confirm that the material meets the claimed potency of active or marker chemical constituents. Depending on the constituent, different instrumental methodologies, such as HPLC, gas chromatography or ultraviolet spectrophotometry, may be used to quantify these chemical constituents.
One of the very first things needed to ensure the quality of botanicals is to create an ingredient specification sheet detailing identity (genus, species, plant part), physical (appearance, particle size, density), chemical (chemical constituents, marker compounds), heavy metal, pesticide and microbiological requirements as well as the preferred sterilization process. Since using different methods could lead to different test results, it is important to identify the sterilization and test method on the specification sheet.
In the case of botanical extracts, the ingredient specification should also list the raw herb-to-extract ratio, extraction solvents used and any excipients and/or carriers that may have been used 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 metal and pesticide residues testing as well as microbiological testing results should be listed on the COA along with the specifications and methods of analysis. The COA should be a guarantee that the product is what it claims to be, is unadulterated and is safe for human consumption. However, the COA provided by the ingredient supplier should be verified and the test methods used should be evaluated. It is important for suppliers and customers to agree on test methodologies prior to accepting COA results.
Ingredient Supplier Selection
A key step in ensuring the quality of finished products is choosing an ingredient supplier that will provide material that meets all of the requirements. The vendor should be provided with the detailed ingredient specification—which should be part of the contract with the customer—so that they can fully understand the customer’s requirements. The supplier should review the specification thoroughly and provide feedback to the customer in the form of comments or ask for further clarification. The customer and supplier should agree on the ingredient specification before placing or accepting orders.
It is very important to review and evaluate the vendor’s capabilities and expertise. Some areas that need to be evaluated are the vendor’s quality unit, including but not limited to the education, training and experience of the quality unit staff. The vendor’s Standard Operating Procedure programs, testing capabilities (including certification of any third-party testing labs used), laboratory equipment, sanitation programs, process control and pest control programs are some of the areas that should be evaluated. It is necessary to assess whether the vendor follows some form of GMPs and Good Laboratory Practices in terms of product and document traceability. A site visit and audit of the vendor facility provide critical information regarding vendor quality.
Since the ingredient supplier receives material from diverse geographic regions, a vendor qualification program is essential to have in place to ensure the quality of raw botanicals received.
It is essential to partner with vendors that understand your quality requirements and are capable of meeting them. It is only through this partnership that we can provide high-quality finished products to consumers.
Rupa Das, M.Sc., is vice president of global quality and compliance for BI Nutraceuticals. She has more than 20 years of quality and regulatory compliance management experience in the dietary supplement and personal care product industries. She is a certified GMP auditor and Safe Quality Foods (SQF) practitioner. She is involved at different levels with leading industry organizations. Prior to her work in the industry, she was a chemistry lecturer at several California State University branches.