Quality Control and Good Manufacturing Practices for Herbalists
From personal dispensary to full scale factory, there are numerous principles and practices that ensure safety, accuracy and accountability in herbal medicine. They are the least a consumer expects of you and they are mostly also required by law. This extensive review of the herbal industry will consider field and farming practices, harvesting and processing practices, how and where adulteration or contamination can occur and how to recognize it, hazard mitigation, traceability and transparency, regulations and requirements of law. It will include a practical session where students will learn to apply organoleptic skills to raw herbs.
- overview of the industry – what is selling, in what channels and how much?
- what is meant by ‘QC”
- adulteration, contamination, substitution
- Botanical Adulterants Program
- Organoleptic evaluation – including a break out session with a hands-on exercise
- Microscopic evaluation
- Product purity
- Plant variability
- Marker compounds
- Certificates of Analysis
- Good Agriculture Practices (GAP):
- Safety, quality assurance and traceability
- Natural Health Products and Health Canada regulations
- Good Manufacturing Practices – Hazard Analysis Critical Control Points
- Adverse Event reporting
By completion of this class the student will:
- Be able to describe the key identifying features of good quality botanical products.
- Be able to identify hazard points in herbal manufacturing – where and why contamination or adulteration can occur and how to avoid it.
- Discuss manufacturing issues and regulatory affairs affecting the botanical market.
Toxicology and Scheduled Herbs
- Discuss toxicology as it applies to botanicals, safety guidelines and adverse events.
- Review rules, regulations and practicing with botanicals in Canada – NHPD, NPNs and scheduled herbs.
- Consider the use of toxic botanicals and safe dosing strategies for a variety of herbs including:
- Aconitum napellus
- Cineraria maritima
- Bryonia spp
- Convallaria majalis
- Datura stramonium
- Digitalis purpurea
- Ephedra sinica
- Gelsemium sempervirens
- Hyoscyamus niger
- Phytolacca americana
- Piper methysticum
- Rauwolfia serpentine
- Veratrum album/viride
By the end of this class students will be able to:
- Discuss safety issues with botanicals including herb / drug interactions and contra-indications
- Describe the safe and appropriate use of toxic botanicals and be able to recognize adverse effects.
- Describe the relative risk:benefit ratio of botanicals and use of toxics in clinical practice.
- Locate and comprehend schedules of restricted herbs in Canada.
- Understand why some herbs are scheduled and determine when and how those herbs may be used, under what circumstances.