Accurately verifying the identity of a botanical ingredient used in a dietary supplement is a critical step to ensure quality and compliance with current good manufacturing practice (cGMP) requirements.

There are many appropriate and scientifically valid methods manufacturers can use to verify the identity of herbal ingredients. Moreover, it does not have to be cutting edge or expensive to be scientifically valid. Botanical, macroscopic and organoleptic analysis of herbs, in as whole form as possible, are the oldest tools used by a trained professional to verify identity of herbs.

These tools are definitive, rapid, environmentally friendly and cost-effective. These are the methods where identity, quality (based on organoleptic characteristics), and the presence of adulterants (foreign organic matters, for example) can be discerned in a single analysis.

Testing Requirements & Tools
In order to ensure accurate assessment of botanicals and compliance with cGMP requirements, botanical, macroscopic and organoleptic analysis needs to be performed by a trained expert and samples should be compared to a voucher specimen. For cGMP compliance, it is also critical to document every aspect of the identification process—including the credentials of the expert performing the analysis, the steps taken to identify and the validity of the voucher specimen.

A voucher specimen is a botanical reference material that has been identified by a trained botanist and is preserved for future reference or analysis. The voucher specimen allows trained experts to compare morphological and/or anatomical characteristics of the whole plant or individual plant parts (e.g., leaf, flower, fruit, seed, root, rhizome and bark) and other characteristics like color, fracture, smell and taste.

Botanical, macroscopic and organoleptic analysis have their own limits. Additional methods like microscopy and chromatography may be needed in some cases to complement botanical, macroscopic and organoleptic analysis, especially for herbal ingredients that have been highly processed and for closely related or look-alike species.

Upcoming Workshop
To help the industry understand the benefits and limitations of botanical, macroscopic and organoleptic analysis of herbal ingredients for cGMP compliance, the American Herbal Products Association (AHPA) is partnering with the American Herbal Pharmacopoeia (AHP) to present a two-day, hands-on workshop at Portland State University in Oregon on June 15-16. Attendees will receive a detailed orientation of botanical, macroscopic and organoleptic identification methods, quality assessment techniques and terminology, and demonstrations on how these techniques are used to evaluate crude plant parts in a scientifically valid manner.

Participants will also receive instruction on preparing botanical vouchers, maintaining an in-house herbarium collection, and examining various plant parts. A Certificate of Completion will also be provided to help meet the cGMP requirement that QC/QA personnel be adequately trained in dietary ingredient testing. The workshop will also cover:

• Botanical identity cGMP compliance requirements;
• Strengths and weaknesses of various analytical technologies (botanical, morphological, microscopic, chemical, DNA);
• Botanical terminology and botanical identification of plant materials;
• Language of botanical pharmacognosy and organoleptics: Terminology and assessment techniques for roots, leaves, stems, barks, flowers, fruits, seeds;
• Developing and documenting macroscopic and organoleptic assessments in a scientifically valid manner;
• Common and uncommon botanical adulterants: how to detect and how to avoid them;
• Sourcing of botanical reference materials and developing internal standards.

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Maged Sharaf, PhD
American Herbal Products Association (AHPA)

Maged Sharaf, PhD, is the chief science officer of the American Herbal Products Association (AHPA), the national trade association with a focus primarily on herbs and herbal products. AHPA’s membership represents U.S. and international growers, processors, manufacturers, marketers and institutes specializing in botanicals and herbal products. Before AHPA, Dr. Sharaf was the director, Foods, Dietary Supplements and Herbal Medicines at the United States Pharmacopeial Convention (USP). Before USP he was pharmacy associate professor and has preceding experience conducting bioanalytical assay development and validation, and human bioequivalence studies in support of the pharmaceutical industry; and quality control and manufacturing of pharmaceutical dosage forms. He can be reached at 301-588-1171; E-mail: [email protected]; Website: www.ahpa.org.