cGMP Compliance Package 2024

cGMP Compliance Package 2024 describes how Vantage Hemp’s CBD Isolates, Distillates, and finished goods are manufactured to WHO GMP, ICH Q7, FDA 21 CFR 210/211, and PIC/S global pharmaceutical standards.

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Download our complete compliance package courtesy of our Chief Operating Officer, Deepank Utkhede and Director of Regulatory Affairs and Quality Assurance, Darcie Moran. Here’s what you can expect to find inside:

  • Statement of Compliance
  • Statement of Origin
  • FMSA Statement
  • Food Grade Statement
  • Third-Party Laboratory Statement
  • Allergen Statement
  • Elemental Impurities Statement
  • Residual Solvent Statement
  • GMO Statement
  • Process Validation & Stability Statement
  • cGMP Certification – ICH Q7 and cGMP Certification – Annex 2 WHO
  • FDA Registration
  • Colorado Department of Public Health & Environment License
  • Ethical Code Statement
  • Phthalates Statement
  • TGA (Australia) PIC/S cGMP Certificate

cGMP Compliance in the CBD Industry

The  US Food and Drug Administration is currently investigating the CBD industry to establish new and effective policies, but today the industry suffers from loopholes. For this reason, current Good Manufacturing Practices (cGMP) play a significant role in ensuring product safety. Today CBD companies are not obliged to report, but have an opportunity for self-regulation to the strictest manufacturing standards. GMP compliance is an indicator to stakeholders across the CBD supply chain that CBD products are examined and manufactured under strict GMP guidelines. The highest quality is guaranteed when a third party is involved in helping to regulate the processes.

Vantage Hemp’s cGMP Certifications

Vantage Hemp takes cGMP compliance seriously. We have worked intensively to improve and develop manufacturing operations to ensure all CBD products meet the required conditions for GMP Manufacturing. These include controlling every step of the manufacturing and materials sourcing process, keeping valid records, and testing batches for safety, potency, and consistency. Vantage is currently certified to ICH Q7, WHO GMP, and FDA 21 CFR 210/211 standards for pharmaceuticals manufacturing.

 

In the currently-regulated market, consumers may be unable to verify the quality and safety of CBD products, but they may rely on cGMP compliance that ensures purity and quality throughout the CBD product manufacturer’s supply chain. cGMP requirements are designed in a way that protects consumer health without limiting or constraining CBD companies in their product formulations and innovations.

 

Vantage’s cGMP certifications were rightfully earned as every step from harvest to sale has been maintained to the highest standards. We deploy innovative manufacturing practices adjusted to cGMP regulations. The company has the flexibility to continue developing its processes without sacrificing the quality of products.

 

Additionally, Vantage has cGMP certifications of American and European standards. We hold GMP compliance enforced by the FDA and GMP compliance that was introduced by the World Health Organization and adopted in the EU, Canada, and other countries.

All of our employees are highly trained in these standards and are independently committed to Quality and Compliance. We each take full personal responsibility for the quality of our work on a daily basis.

 

Vantage’s wide range of wholesale hemp-derived CBD products includes CBD Isolate, CBD Distillate, CBD Broad Spectrum Distillate Oil, CBD Full-spectrum Oil, CBD CO2 crude and Hydrocarbon crude. All are derived from industrial hemp that is exclusively grown, harvested and dried in the United States by growers who have been qualified through our Biomass Compliance Program.

 

Vantage Hemp is licensed and regulated by the state of Colorado’s Department of Public Health and Environment and is also registered with the US Food and Drug Administration as a food manufacturing facility. We far exceed all FDA food regulations, and our products all meet or exceed the definition of industrial hemp via the 2014 and 2018 Farm Bill.

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