Our mission at Pure Hemp Botanicals is to deliver high quality, hemp-derived CBD products that meet all specifications. Our production facility is operated by seasoned professionals who, combined, have more than 75 years experience in manufacturing of compliant dietary supplements, not just CBD-related. To ensure that our products are safe to consume and meet label claims, we implement quality systems that meet the highest industry standards. Compliance with quality systems provides assurance that every dietary ingredient, intermediary material, and in-process material used in a finished product meets specifications, and assures that every finished product meets quality standards and finished product label claims. Then we prove it through audits by 3rd party companies who certify us for safe production of dietary supplements and foods to meet rules of various governmental agencies.
What are GMPs, SOPs, and Why Do We Need Them?
We have established GMPs (Good Manufacturing Practices) for all aspects of our hemp and CBD production sub-systems, including operations, quality, equipment, packaging, and warehousing/shipping. GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. We’ve established GMPs:
- to ensure the integrity of production quality systems and manufacturing practices.
- to ensure Pure Hemp Botanicals finished CBD products meet our set quality standards.
- to provide an explanation of our production quality systems and manufacturing practices to customers who request this information.
- to provide these GMPs as a formal written document to any international, federal, or state governmental agency that might request this information.
Standard Operating Procedures (SOPs) have been written for all subsystems at a process level. Further, standardized work instructions are written to correlate the product-specific process with Standard Operating Procedures (SOPs). The objective of all this organization and documentation is to present our quality systems and manufacturing practices as an interrelated and integrated web of interactive subsystems.
Which Government Agencies Have Certified Us, For What?
Pure Hemp Botanicals production facility and quality control systems have been certified by various independent agencies for safe, high quality CBD production, but the most important of these are:
FDA 21 CFR 111
The FDA has registered our facility as a producer that complies with FDA 21 CFR Part 111 regulations for production dietary supplements. These rules require that the proper controls be in place during manufacturing, packaging, labeling, and holding operations. The independent company SGS regularly audits and certifies the production facility.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA to ensure that quality and safety is built into the design and drug manufacturing process at every step. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Again, the 3rd party auditors of SGS validate the strength, purity, and safety of all our products. This certification demonstrates that our production facility and manufacturing operations include strong quality management systems, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, safe and pure raw materials, and high-caliber testing.
We are registered with the Colorado Department of Public Health and Environment (CDHPE) as a facility for processing hemp material and products intended for human consumption. CDHPE verifies that our facility follows cGMPs for all operations related to manufacturing food and ingestible products.
Our NASC (National Animal Supplements Council) Quality Seal identifies our commitment to quality, vigilance, and continuous improvement to promote the well-being of companion animals and horses. As a member of the NASC, our manufacturing arm follows strict guidelines for using SOPs for product quality assurance, adverse event reporting, and labeling standards. Pure Hemp Botanicals production facility is audited every two years by a third-party inspector.
The Colorado Department of Agriculture’s Hemp Program regulates cultivation of hemp in the state of Colorado. Pure Hemp Botanicals has earned credibility as a trusted producer of all-natural, locally-grown hemp products. Our premium hemp extracts are sourced and manufactured by our CDA-registered facilities for safety and quality.