Manufacturers of products containing CBD and THC in the US vary widely in terms of their compliance with cGMP, manufacturing processes, as well as testing applied to these products that are sold in pharmacies and dispensaries. Therefore, the quality of the final product sold to the consumer may be highly variable depending on State laws, regional quality expectations as well as the capability, processes and production of the manufacturer.
USQC provides full product certification services that will allow your cannabis-related product to carry our Seal of Quality on the label. Display of the USQC Seal on your products gives consumers confidence that they are purchasing a product that meets high standards for quality and is free of heavy metals, pesticides, and other harmful impurities that may be present in products that are made outside of quality standards. Analysis in consumer purchasing behavior indicates that consumers a) prefer products (e.g. dietary supplements) associated with a standard for high quality, and b) are willing to pay a premium (up to 18% more) for trusted quality products.
Services include:
Detailed Document Review
We provide an in-depth review of…
- Documentation review:
- Product formulation
- Manufacturing
- Control of materials and critical steps
- Process validation and/or evaluation
- Specifications for ingredient(s) and finished product
- Validation of analytical procedures
- Container closure system and labeling
- Stability procedures
Full cGMP Audit
The three-day onsite audit evaluates your current manufacturing processes to ensure full cGMP compliance. When full cGMP requirements are met, USQC will provide a certificate of cGMP compliance. This certification indicates to your customers and regulatory authorities that your manufacturing processes and procedures are up to the same standards as a dietary supplement and/or foods manufacturers (per 21 CFR Part 111 and/or CFR Part 117), or a pharmaceutical manufacturer producing medicinal marijuana, (per CFR Part 210/211).
Our GMP auditing services include:
- Vendor and supplier confirmation
- Risk assessment and risk mitigation plans
- Quality System and corporate SOP Analysis
Cannabis Product Testing
We provide a full quality evaluation of your products against the independent, scientifically vetted standards published by USP. Our trusted, independent network of ISO 17025 certified testing laboratories will evaluate samples of your products for the following Cannabis Quality Criteria framework:
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| Identification | Active Ingredient Control | Limits for Contaminants | Product Tests |
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The USQC will perform testing on a select number of lots for certification purposes. Program participants will be required to perform testing on each lot of product by a laboratory within our network of trusted qualified testing laboratories. This transparent process provides the consumer with important information as to how the quality of their product was determined.