The Bastyr Dispensary makes every effort to provide the highest quality products for patients and customers. To that end, all prospective vendors are required to complete a quality assurance questionnaire to ensure they are complying with good manufacturing practices (GMPs) as required by the U.S. Food and Drug Administration (FDA). GMPs include handling and testing raw materials, record keeping, standards for cleanliness and safety, production and process controls, labeling practices, and warehousing and distribution.
The vendor questionnaire includes inquiries to assure that herbal products received have been harvested using sustainable methods, and have been appropriately tested for identity, quantity and contaminants. Verifiable safety and purity of herbal products carry great significance due to the many variables involved in the growing of herbs; factors considered include the time and method of harvest, country of origin, locale and susceptibility to contamination.
In addition, prospective vendors must submit the following documentation:
- A copy of the most recent GMP audit results.
- Examples of analysis results completed on raw and finished products within the last year, including:
- Identity and quantity assay results
- Heavy metal analysis results
- Bacteria, mold, yeast assay results
- Pesticides/herbicides assay results
- Copies of the following documentation:
- Liability insurance
- Detailed Standard Operating Procedures (SOPs) that include procedures for personnel, plant and grounds, equipment and utensils, quality control and laboratory operations, production and process controls, warehouse, and distribution and post-distribution procedures
- Submission of any supportive studies on finished product is also encouraged.
Completed vendor questionnaires and documentation are then reviewed and evaluated by Kathie Golden, ND, Bastyr Center product review coordinator.
For more information, call the Bastyr Dispensary staff at (206) 834-4114.