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August 28, 2024 Our Quality Differentiator

How HOH Achieved cGMP Excellence & Secured Global Market Growth

Quality, compliance, and operational efficiency aren’t just buzzwords - they’re essential for long-term success. Our story is a powerful example of what’s possible when a company goes beyond the basics and commits to achieving the highest standards. Recently featured in a detailed case study, our journey towards cGMP (Current Good Manufacturing Practice) excellence showcases how we overcame challenges, leveraged innovative technology, and successfully entered new global markets.

 

The Challenge

Established in Michigan in 2018, HOH had a clear mission: to become a leader in the domestic and export markets for high-quality CBD products. From the outset, we took control of every step in the process - cultivating, harvesting, processing and formulating our own proprietary extractions to ensure unmatched quality. But we knew that maintaining quality while scaling operations, particularly for export markets, would require us to adopt a more rigorous system for compliance and quality management.

Brazil became a key market for us to expand into, but this market is known for its strict regulations. We needed to achieve cGMP accreditation not just to comply with Brazilian regulations, but also to ensure that our processes met global standards for safety, consistency, and efficacy. This was where the C15 electronic Quality Management System (eQMS) came into play.

 

The Solution

Our partnership with C15 Solutions proved to be transformative. Through their eQMS, we were able to automate many of the time-consuming, manual processes that are typical in compliance-heavy industries. The system offered a comprehensive suite of tools designed to help us meet and exceed regulatory requirements, while also enhancing our operational efficiency.

Key features included:

  • Document Management: Automating Standard Operating Procedures (SOPs) and workflows to streamline documentation and ensure that all processes were properly recorded.
  • Employee Training: Ensuring compliance with 21CFR11/EUAnnex11 through comprehensive training modules and record-keeping, so every team member was prepared to meet our high standards.
  • HACCP (Hazard Analysis and Critical Control Points): Implementing food safety controls to mitigate contamination risks, ensuring that our products were safe and consistent.
  • Electronic Batch Records: Digitizing batch records to maintain accuracy, reduce paperwork, and enable real-time monitoring of production.
  • Continuous Improvement: A continuous re-evaluation of our processes to ensure we were always aligned with best practices.
     

This solution allowed us to focus on our core activities - producing high-quality CBD products - while automating the complex, critical tasks that come with compliance and quality assurance. The C15 eQMS also helped us stay on top of global regulatory standards, including FDA regulations and ISO compliance, which further positioned us as a trusted partner in the international market.

 

The Outcome

The results of our collaboration with C15 Solutions were nothing short of remarkable. We achieved a 99% pass rating during our cGMP audit, a critical step in our two-stage approval process with Brazil's regulatory agency, ANVISA. This achievement not only validated the quality of our products and processes but also enabled us to secure an exclusive export arrangement to Brazil’s medical market through Medra Brazil.

Securing this partnership was a significant milestone for HOH. Brazil represents a growing market with immense potential for medical CBD products, and our ability to meet their rigorous standards opened the door for us to expand our footprint globally.

 

Setting the Standard for Quality and Global Expansion

The HOH case study is a testament to what can be accomplished when quality and compliance are placed at the heart of a company’s operations. Our partnership with C15 Solutions helped us automate critical functions, achieve a 99% cGMP rating, and secure our place in Brazil’s burgeoning medical market. Moving forward, we’re excited to continue this journey of innovation and excellence, setting new standards for the global CBD industry.

 

Read the full case study here

 

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