San Francisco, California
London, United Kingdom
Hosted by BioNetwork, American Herbal Pharmacopoeia, North Carolina Arboretum Germplasm Repository, and CAMAG Laboratory.
Join us April 22nd - 25th, 2014 for this four-day series of lectures, discussions, and interactive workshops designed to help dietary supplement companies better understand how to develop identity specifications per the Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP) under the Code of Federal Regulations (CFR) 21 part 111.
Led by academic and industry professionals, participants will not only gain a better understanding of how identity testing cGMPs effect their company, they will also learn affordable techniques that can be used to help their company maintain high quality standards as well as cGMP compliance.
- Current compliance requirements
- Macroscopic and organoleptic characterization of botanical ingredients
- High performance thin layer chromatography
- Voucher specimen preparation protocols
- Taxonomic identification
- Microscopy basics
- Retention sample storage protocols for botanical products
- Roy Upton, RH, DipAyu – American Herbal Pharmacopoeia™
- Judy Nichols – CAMAG Laboratory
- Joe-Ann McCoy, PhD – North Carolina Arboretum Germplasm Repository
Registration includes all four days of courses as well as lunch each day.
Day 1 - Macroscopy and Organoleptics, Roy Upton
The first day (and a half) of this workshop will introduce participants to the basics of conducting macroscopic and organoleptic characterizations of botanical ingredients and how these techniques can be applied to fulfill the requirement for the identification of botanical ingredients for Dietary Supplement GMP compliance. Topics covered will include Macroscopy and Organoleptics as outlined in GMPs, language of macroscopy and organoleptics (look, feel, aroma, taste, fracture), basics of sensory perception, assessment of various forms and grades of botanicals, documentation, and a focus on adulterations.
Day 2 - Macroscopy and Organoleptics (continued) and Introduction to Microscopy, Roy Upton
Botanical microscopy was the cornerstone of botanical ingredient quality control from the late 1800s to the 1950s. Microscopy remains an extremely valuable and low cost assessment tool for differentiating between closely related plants and detecting foreign matter and impurities in a single analysis. While competency with botanical microscopy can only come with experience and time, this session will introduce the theoretical foundation that will be built on during the following days session.
Day 3 - High Performance Thin Layer Chromatography (HPTLC) for the Identification of Botanical Materials, Dr. Eike Reich and Judy Nichols
HPTLC is widely accepted by pharmacopoeias, industry, and regulatory agencies as a well-suited tool for the identification of dietary supplements, powdered herbal material, and extracts. The availability of valid methods that are fit for purpose is increasing as more monographs are being published. Analysts are beginning to adapt a standardized methodology for HPTLC, and SOPs for development and validation of methods are being followed.
This session will introduce: current concepts of HPTLC; its applicability to the analysis of botanical materials including the identification of raw materials and finished products; the detection of adulteration (related species, chemicals); the quantitative determination of markers; and investigations of shelf life. The focus will be on the actual analytical process and its parameters in a cGMP compliant environment. SOPs are introduced and applied in a hands-on lab session. Sources of methods and their utilization will be discussed along with principal elements of validation.
Day 4 - Microscopy Basics, Voucher Specimen Preparation, and Retention Sample Storage Protocols for Natural Products, Joe-Ann McCoy, PhD
This session will cover botanical identification and traceability techniques related to microscopy, voucher specimen preparation protocols, and retention sample storage protocols for botanical products. The workshop will include both a lecture and hands-on format to introduce attendees to quality control methods that are easily adapted to both small and large production facilities.
When & Where
BioNetwork is part of the North Carolina Community College System and is hosted by community colleges throughout the state.
The mission of BioNetwork is to provide high quality economic and workforce development for biotechnology and life science industries across North Carolina through education, training, and laboratory resources.
For additional educational opportunities and resources, visit ncbionetwork.org.