Quality control is vital for botanicals

Manufacturers looking to market quality herbal products — and have repeat customers — need to partner with dependable, quality-conscious suppliers. Rupa Das explains the things to look for upon receipt of your next batch of botanicals

As the dietary-supplements industry grows, so do the questions and concerns regarding quality of dietary supplements. Most, if not all, quality-related questions can be answered by evaluating the cultivation and harvesting practices, the manufacturing practices, and the quality-control programme adopted by the ingredients suppliers.

A good-quality dietary supplement is one that uses the correct plant species and plant part, and is unadulterated, safe for human consumption and has the potency (level of chemical constituents) it claims. Different types of identification methods — macroscopic, microscopic, organoleptic, TLC, HPTLC, HPLC, FTIR — 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 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 assure the product is free of pathogenic bacteria and is safe for human consumption. Raw botanicals usually have high microbial load and therefore require some form of sanitisation to lower the microbial load. Several different sanitisation options are available. But it is important to understand the regulatory and quality impact of such sanitisation processes prior to 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 type of chemical constituent, different instruments, such as HPLC, GC or UV spectrophotometer, may be used to quantify these chemical constituents.

One of the challenges the industry faces today is the lack of standardised methods. Different methodologies produce 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 organisations currently are working toward standardisation of testing methodologies.

Manufacturing practices
Quality of herbal products is also affected by the manufacturing processes. Cross-contamination with other products, environmental contamination, mix-ups or mislabelling could lead to poor-quality material. These can be reduced by implementing Good Manufacturing Practices (GMP). The challenge that the industry faces in this respect is that it is still awaiting the final ruling for dietary supplement GMP. Quality-conscious ingredients suppliers have adopted some form of GMP, whether it is drug, food, proposed dietary supplement or a combination of the three.

Along with this is the challenge that dietary supplements ingredients are sourced from diverse geographic locations. Although most of these locations have some form of GMP, the standards and enforcement are not the same. It is therefore important to check and evaluate the manufacturing practices of suppliers, to assure high-quality botanical products.

Ingredient specifications
One of the very first things needed to assure the quality of botanicals is to create an ingredient specification sheet detailing the identity (genus, species, plant part), physical (appearance, particle size, density), chemical (chemical constituents, marker compounds), heavy metal, pesticides and microbiological requirements. Because using different test methods could lead to different test results, it is important to identify the test method on the specification sheet. Because raw botanicals have high microbial loads, the product may have to be sanitised to meet microbiological requirements and to make the product safe for human consumption. The product specification should, therefore, outline the type of sanitisation process acceptable, to reduce micro load.

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.

Certificates of Analysis (COfA)
The ingredient supplier should provide a CofA with all shipments. The results of identity, physical, chemical, heavy metal, pesticide residues and microbiological testing should be listed on the CofA, along with the specifications and methods of analysis. The CofA should be a guarantee that the product is what it claims to be, and is unadulterated and safe for human consumption. However, the CofA 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 CofA results.

Choosing the right vendor
A key step in assuring the quality of finished botanical dietary supplements is choosing an ingredient supplier that will provide material that meets all of the requirements. The vendors should be provided with the detailed ingredient specification, so that they can fully understand the customer's requirements. The specification should be a part of the contract between the customer and the supplier. The supplier should review the specification thoroughly, and provide feedback to the customer in the form of comments, or ask for further clarifications. The customer and supplier should agree on the ingredient specification prior to 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. A vendor's SOP (Standard Operating Procedure) programmes, testing capabilities, laboratory equipment, sanitation programme, process control, and pest-control programme are some of the areas that should be evaluated. It is necessary to assess whether or not the vendor follows some form of GMP and GLP (Good Laboratory Practices) in terms of product and document traceability. A site visit and audit of vendor facility provides critical information regarding vendor quality.

Because ingredients suppliers receive material from diverse geographic regions, it is important that the ingredients suppliers also have a vendor qualification programme in place to assure the quality of raw botanicals they receive.

It is important to partner with vendors who understand your quality requirements and have the capability to meet them. It is only through this partnership that high-quality botanical dietary supplements can be provided to consumers.

Rupa Das is vice president of global quality and compliance for BI Nutraceuticals. She develops, implements and manages the quality-assurance, quality-control and regulatory systems for BI. She also has developed and implemented a quality surveillance programme for BI's China group.
Respond: [email protected]

Regulatory developments across the world
Africa: South Africa is still in the process of developing its new regulations on complementary medicines that will include regulations for botanicals sold as traditional medicines and dietary supplements. Progress on this is expected during the course of 2007.

Japan — A number of botanicals are projected to move from drug-only status to food status, including hawthorn and persimmon, in a review carried out by the authorities.

ASEAN — Harmonisation is under way of the 'health supplement category' across the 10 countries of SE Asia that make up the ASEAN group. The target is to have the key elements of a new regulatory model agreed upon by 2010, including the range of botanicals that can be used in this category.

EU — The European Commission will be publishing by July this year its ideas on whether the EU's food-supplements directive should be expanded to give precise rules on substances such as botanicals, which are currently largely regulated by national law. In addition, the claims that can be made for botanicals used in foods and food supplements must be listed by the end of this year to give them a chance of being permitted in the future in these product categories.

EFSA — The European Food Safety Authority is developing a negative list of botanicals that may not be used in food.

— Pieter Lagae, regulatory and marketing adviser, EAS

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