Botanical Raw Material Qualification

Major retail brands in the dietary supplement industry have been in the limelight recently due to the investigations and accusations by the Office of New York Attorney General Eric Schneiderman. While we may continue to argue about the validity of the tests conducted by the AG’s office, we cannot undermine the fact that consumers deserve safe and efficacious products that meet label claims.

The quality of the products consumers buy and use does not start and end at the manufacturing site that makes the tablets, capsules, softgels or any other modes of administration of herbal products. It starts with the quality of the raw material that the manufacturing site purchases. You cannot make good product with bad ingredients. Hence, raw material qualification is of utmost importance in every industry.

The major aspects of botanical raw material qualification are to assure the plant part, genus and species used is correct, unadulterated, safe for human consumption and has the potency (level of chemical constituents) it claims. Raw material qualification is a stepwise process.

One of the very first things needed to assure finished product quality is for manufacturers to create ingredient specifications detailing the identity (genus, species, plant part), physical (appearance, particle size, density), chemical (chemical constituents, marker compounds), heavy metal, pesticides, solvent residues and microbiological requirements. The limits for all parameters should be clearly identified on the ingredient specification. Since using different test methods could lead to different test results, it is important to identify the test method on the specification sheet. Raw botanicals have high microbial load and may have to be sanitized to meet microbiological requirements and to make the product safe for human consumption. The product specification should therefore outline the type of sanitization process acceptable to reduce micro load. In the case of botanical extracts, the type of solvents used for extraction should be identified on the ingredient specification.

Raw material quality control (QC) does not start and end at the manufacturer. It starts at the farm/field level depending on whether the botanical is cultivated or wild-crafted. Most, if not all, quality-related questions can be answered by evaluating the cultivation, wild-crafting, harvesting and drying practices—the processing practices and the quality assurance (QA) programs adopted by the botanical ingredient suppliers. It is important to identify vendors that understand your quality requirements and have the capability to meet them. It is therefore crucial to agree upon the raw material specification and testing methodologies with the ingredient supplier.

It is critical to review and evaluate vendor capabilities and expertise. Some areas that need to be evaluated within the vendor’s quality unit include—but are not limited to—the education, training and experience of the quality unit staff. A vendor’s standard operating procedure (SOP) programs, testing capabilities, laboratory equipment, sanitation program, process control and pest control program are some of the areas that should be evaluated. It is necessary to assess whether the vendor follows GMP (good manufacturing practice) and GLP (good laboratory practice) in terms of product and document traceability. A site visit and audit of a vendor’s facility can provide critical information regarding vendor quality. Appropriate third-party certifications related to GMP and food safety may be used in lieu of a facility audit. Since the ingredient supplier receives material from diverse geographic regions, it is important that the ingredient supplier has a robust supplier qualification program in place to assure the quality of raw botanicals it receives. All raw materials should have complete traceability from the farm/field to the manufacturers’ receiving docks. Documentation on all supply chain processes including identity, purity, quality and safety of the raw material should be maintained.

The regulatory climate for ingredient suppliers has changed over the past few years. Foodborne illnesses have prompted the Food Safety Modernization Act (FSMA). 21 CFR 117 is a major overhaul to the current good manufacturing practices (cGMPs) outlined in 21 CFR 110. Compliance with these laws by ingredient suppliers is required.

Testing at different stages of the supply chain assures the quality of the raw material. Different types of identification methods such as macroscopy, microscopy, organoleptic, TLC, HPTLC, HPLC, FTIR and DNA may be used to identify the genus, species and plant part. Each of these identity tests has advantages and limitations. The type of identification method(s) used should be specific enough to differentiate between the species and plant parts. In most cases, a combination of different methods is required 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, irradiation and ethylene oxide residues. In the case of botanical extracts, testing of residual solvents is also critical. Most countries have regulatory guidelines related to adulterants, and products must meet these guidelines.

Microbiological testing is required to assure the product is free of pathogenic bacteria and is safe for human consumption. As mentioned earlier, raw botanicals usually have a high microbial load and therefore require some form of sanitization to lower the microbial load. Several different sanitization options are available. But it is important to understand the regulatory and quality impact of such sanitization processes prior to choosing one that is appropriate for the specific product. Since irradiation and ethylene oxide treatment are not allowed for dietary supplements, it is important to verify these treatments were not used at any point in the supply chain.

Chemical tests are required to confirm that the material meets the claimed potency of active or marker chemical constituents. Depending on the type of chemical constituent, different instruments such as HPLC, GC, GC-MS or UV spectrophotometer may be used to quantify these chemical constituents.

Along with appropriate specifications and testing, partnership with a dependable, quality-conscious ingredient supplier is key to the success of the manufacturer and to the industry as a whole. Raw material qualification and robust vendor qualification go hand-in-hand. Robust raw material and vendor qualification can ultimately reduce the burden of testing at the manufacturer’s receiving dock.

Rupa Das is the vice president of global quality and compliance at BI Nutraceuticals. She has 20 years of quality and regulatory compliance management experience in the dietary supplement and personal care product industries. She is a certified GMP (good manufacturing practice) auditor and is involved at different levels with leading industry organizations. Das is also a member of the American Herbal Product Association’s (AHPA) board of trustees.