Quality Control of Botanical Ingredients
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.
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 . 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. In most cases, different methods must be combined to identify the plant species and plant part beyond a reasonable doubt.
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.
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. A site visit and audit of the vendor facility provide critical information regarding vendor quality.