CBD Softgel cGMP Manufacturing | Denver Colorado

QUALITY

Cannoid operates a state-of-the-art manufacturing facility in Denver registered with FDA and CDPHE and 3rd-Party audited to cGMP compliance per FDA 21 CFR 111, 21 CFR 117, and 21 CFR 211 (drug). Our Quality Management System (QMS) features process control from ISO 9001, and advanced risk management and mitigation adopted from ISO 13485 and 21 CFR 820 for medical devices and international harmonized quality standards for pharmaceutical manufacturing under ICH Q9. We seamlessly integrate with our customers’ internal quality management systems for all aspects of production, from vendor qualification and feedstock validation through lot-controlled and traceable materials and finished goods.

With respect to contract manufacturing, our QMS focuses on three main areas: 1) Control over incoming materials and supply chain; 2) Control over work in progress and manufacturing processes; and 3) Control over finished goods and distribution: traceability, customer feedback, and corrective/preventive actions.

INCOMING MATERIALS

All ingredients are quarantined and tested for contaminants, and in the case of CBD feedstock, compliance to federal THC limits and state cultivation registrations.
Our organic hemp seed oil and other food-grade carrier oils are tested for peroxide value (PV) to detect oxidation (rancidity) before it is allowed on the production floor.
All printed materials (labels and boxes) are inspected for compliance before release to production.
Customer-provided oils are subjected to rigorous analysis and testing before they are allowed into production. We don't allow dirty oil on the production floor, regardless of who owns it.
Bottles, caps and other "barrier" materials undergo detailed compliance testing before use.

PROCESS CONTROL

Airtight control on the plant floor. Orders are processed through the system with control over every aspect of the manufacturing process.
Every component of manufacturing is documented at the batch level. Retain samples and associated documentation are archived for 5 years.
Blended oils are assigned unique process-level lot codes to ensure they are never mixed up.
Personnel are only allowed to release product to assembly after confirmation of specifications, customer ID, and lot.
All manufacturing processes are supported by the latest GMP protocols for safety, sanitation, and personnel training.

OUTGOING MATERIALS

Assignment of unique identifiers on all finished goods, including lot numbers, bar codes, QR-codes, expiration dates, and retail/shipping labels compliant to the latest logistics standards.
Comprehensive finished goods documentation, including COA decks, chain-of-custody forms, MSDS sheets, organic certification sheets, and hemp cultivation compliance and registration.
Efforts are taken to maximize shelf life stability, including bottle seal and shipping carton integrity testing. We also nitrogen-blanket our open systems (tinctures), we control humidity on gelatin products (softgels), and we use natural anti-oxidants to extend shelf life on raw carrier oils (organic hemp seed oil).