At Bastyr Dispensary, we make every effort to provide the highest quality products to our patients and customers. To that end, we require all prospective vendors to complete our quality assurance questionnaire. Our questionnaire is designed to assure that our vendors 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.
Our 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; we consider the time and method of harvest, country of origin, locale, and susceptibility to contamination.
In addition, we request that prospective vendors submit the following documentation:
1) A copy of the most recent GMP audit results.
2) 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
3) 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
4) 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.
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