In order to assist manufacturers and suppliers in meeting the burdens of verifying the identity of botanical ingredients under the Food and Drug Administration's good manufacturing practice (cGMP) and to protect them from potential liability, the American Herbal Products Association (AHPA) is presenting a two-day educational training program, "Microscopic Identification of Popular Botanical Materials."
The hands-on program is scheduled for the weekend of May 7-8, 2011, at Rutgers University in New Brunswick, N.J. Early registration, which offers a $150 savings, expires April 1. Elan Sudberg, CEO of Alkemist Pharmaceuticals, will teach the course.
The federal cGMP regulation (21 CFR 111) requires that all dietary ingredients be tested or examined to verify identity prior to use in a finished product.
The material presented will familiarize participants with the various plant parts at the macroscopic level to create an understanding of the characteristic cellular features of each plant part using botanical-microscopy techniques developed over the last century by botanists all over the world.
"It was probably one of the most useful 'short courses' I've ever taken," says David R. Schroeder, who works in the quality control division for Standard Process, Inc., in Palmyra, Wis. "I'd done a lot of reading on botanical microscopy, but none of it was really 'clicking' until I took this course."
The program's overall goal is to have participants leave with the experience necessary to confidently conduct microscopic analysis on a variety of popular botanical ingredients. Additional program objectives:
· Provide the beginning to intermediate microscopist the skills and ability to confidently and competently analyze popular botanical ingredients often used in commercial products;
· Provide hands-on experience: The majority of the program (~75%) will be spent on the use of the microscope and the analysis of botanical materials, including:
o Example preparation and review
o Identification of adulterated material, including common fillers used to "cut" materials, such as flow agents & soluble excipients
o Connecting the dots: Comparing a Certificate of Authenticity (COA) and specifications to micro-analysis results;
· General background on microscopy and usage of a microscope;
· Identification of appropriate reference resources:
o Voucher specimens
o Published references.
Information will be presented in morphological groups such as barks, roots, leaves, seeds, etc., and their characteristic microscopic components. The basic structure of the various tissue types will be discussed and identified using actual examples from a vast database of microscopic botanical images. Participants will spend a significant amount of time during the program conducting hands-on training using a microscope. Equipment, chemicals, and supplies will be discussed, if time permits and/or if requested.
Who Should Attend?
The "Microscopic Identification of Popular Botanical Materials" seminar is geared toward laboratory personnel, QA/QC personnel, dietary supplement companies looking for economical means to comply with the cGMP requirements regarding establishing identity, or anyone with an interest in utilizing microscopy as a tool for the identification of botanicals.
For Registration and More Information
About the American Herbal Products Association
The American Herbal Products Association is the national trade association for and voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers and marketers of herbs, botanicals and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. www.ahpa.org