gmp certified cbd oil for pain

What and Why?

CBD (Cannabidiol) is one of over 85 unique compounds found in hemp, known as cannabinoids.

Cannabinoids, which can be either consumed (phytocannabinoids) or produced naturally by the body (endocannabinoid), work with a series of receptors known as the endocannabinoid system (ECS). This system is known to manage homeostasis and regulate bodily processes such as appetite, mood and sleep.

CBD is non-psychoactive and will not get you high. CBD and the ECS helps keep our bodies balanced day to day, with benefits that may positively affect: pain sensation, memory, immune system functions, and inflammation control.

Our Source Lab

We use one of the premier industrial hemp companies for manufacturing, processing and fulfilling CBD oil.

Their compliance/certifications include:

  • Colorado Department of Public Health & Environment (CDPHE) Accreditations
    • 0.0% THC (Third party tested)
    • 100% on CDPHE inspection
    • Free Sale Certification
    • License to Operate: Manufactured Food Establishment

    Through subsidiary and ancillary companies:

    • Good Pharmaceutical Practices (GPP) certification
    • Active Pharmaceutical Ingredient (API) licensing
    • EU Pharmaceutical Manufacturing licensing
    • ISO Certified Clean Rooms for processing and R&D development

    Active CBD Ingredient

    HydroPCR™ is a 4% w/w Phytocannabinoid-Rich (PCR) Hemp Oil Nanoemulsion from Folium Biosciences. Built with Nano-Enhanced Absorption Technology (NEAT), this water-soluble formula is made with Broad Spectrum 0.0% THC hemp oil rich in phytocannabinoids and contains substantially reduced amounts of natural surfactants compared to competing technologies. The manufacturing process uses a proprietary technology that breaks down cannabinoids into nanoemulsions 20-100 nm in size, thus increasing surface area, bioavailability, and shelf-life of the formulated products.

    PCR Hemp Oil is a precious hemp oil derived from organically grown hemp and one of the best on the market. It is rich in terpenes and has a high concentration of CBD.

    The natural emulsifiers are derived from the soap bark tree and are organic, preservative free, and Generally Recognized as Safe (GRAS). The very low ratio of surfactants to cannabinoids ensures that very little emulsifiers are consumed, resulting in an exceptionally safe and efficacious CBD product.

    Certificates of Analysis (Third Party Testing)

    The PCR Hemp Oil used in Cannafizz is lab-tested to assure the final product is of integrity, consistency, and free of contaminants and heavy metals. Third party tests ensure accurate levels of phytocannabinoids and confirms the absence of THC.

    Cannafizz is routinely tested for CBD potency by an independent third party lab to ensure our soda is accurately infused with proper levels of CBD from start to finish of each batch.

    GMP Certificate

    Bedrocan is the world’s first producer of medicinal cannabis to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards.

    Our GMP-approved production facilities in the Netherlands covers the whole production process including:

    No other company is yet capable of achieving this.

    End-to-end

    GMP may apply to only a single step, or the entire production process. At Bedrocan, GMP is not just about the packaging of cannabis flos, or production of an oil extract. Bedrocan is the only end-to-end producer of GMP-certified medicinal cannabis flos, anywhere. Our GMP practices start from the very first step, the clone, right through to the finished product, cannabis flos (the whole, dried flower).

    All Bedrocan facilities operate according to GMP guidelines, which is an inherent part of the Bedrocan Quality Management System. Each location clearly documents all aspects of the production and testing process. Our personnel, premises and materials meet the highest standards.

    Batch-to-batch

    Medicines must have a clearly defined composition. Because of our unique standardisation method we meet this important GMP requirement. This means the cannabinoid and terpene content is consistent from one batch to another.

    Such consistency is important for:

    • Doctors and their patients – to assure dosage composition and repeatability
    • Researchers – to compare findings from clinical trials and studies across time
    • Industry – to access GMP-certified active pharmaceutical ingredient, and therefore guarantee seamless GMP manufacturing

    Reliable and safe products for patients

    Our products are reliable because each variety contains a consistent amount of cannabinoids and terpenes. They are also free of contaminants such as microbes, pesticides and heavy metals. These qualities make Bedrocan cannabis flos safe for vaporization and inhalation into the lungs.

    Availablity

    Since 2003, Dutch patients have had access to the high quality medicinal cannabis produced by Bedrocan. Today those same quality products can now be found in many pharmacies worldwide. Bedrocan’s Dutch grown cannabis flos is supplied to patients and researchers in Australia, Denmark, Finland, Germany, Italy, Israel, Macedonia, the Netherlands and Poland.