AHPA-AHP Workshop: Botanical, Macroscopic and Organoleptic Assessment of Herbal Ingredients for cGMP Compliance

This seminar addresses macroscopic identification of botanical dietary ingredients, a cornerstone of the FDA's dietary supplement cGMPs

This hands-on, two-day workshop will provide a detailed orientation of botanical, macroscopic, and organoleptic identification methods, quality assessment techniques and terminology, and demonstrate how these techniques are used to evaluate crude plant parts in a scientifically valid manner.

Botanical identification, using classical botany as the basis, is the primary manner in which plant materials are identified. Macroscopic and organoleptic analysis are among the most rapid, accurate, cost-effective, and environmentally sound of all the analytical technologies used for identification and quality assessment of crude herb materials.

Topics

Botanical identity current good manufacturing practice (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.

Discussions will be accompanied by hands-on instruction for:

Preparing botanical vouchers and an in-house herbarium collection;

Examining various plant parts provided during the instruction.

The cGMP rules require QC/QA personnel to be adequately trained in dietary ingredient testing. Each participant shall receive a Certificate of Completion to document attendance.