OVERVIEW OF THE MARKET
The global cannabidiol (CBD) market was valued at 4.9 billion USD in 2021 and is projected to attain a value of 47.22 billion USD by 2028 at a compound annual growth rate (CAGR) of 21.3% during the 2022-2028 forecast period.
While the industry and consumers are appreciative of CBD’s federal legality, the current regulatory landscape has allowed for an influx of CBD products of varying qualities to enter the market. Inconsistent regulations – or no regulations at all – in individual U.S. states, for example, have created problems for manufacturers.
One company, Vantage Hemp Co., stands out for its dedication to providing access to pharmaceutical-grade products and finished goods. Yet to meet the growing demand for clinical studies and commercial supply, products must be consistently manufactured to global cGMP standards and meet jurisdictional regulations.
With cannabis and hemp legalization creating one of the fastest-growing industries of our time, the emerging market has seen institutional voids. Consumers must demand uncompromising quality and refuse to settle for less, but they should be able to expect safety and accuracy in the products available to them in the market. Market pressure continues to increase on cannabis and its adjacent industries to adopt standardized, automated methods to improve quality, consistency, and compliance.
Designed to foster this growing market, an electronic Quality Management System (eQMS) enables cannabis companies to focus on their core activities and objectives while automating many critical, compliance-oriented processes across the operation to ensure compliance, quality, and data integrity.
In order to establish a genuine ‘culture of quality’, companies must invest wisely in their people, processes, and technology.
Ultimately though, people leave and processes change; technology can minimize the associated disruption.
Located in Greeley, Colorado, Vantage’s facilities span over 60,000 sq. ft. Vantage is a globally accredited plant-based extractor and manufacturer, built and operated to WHO GMP, FDA 21 CFR 210/211, and ICH Q7 standards. Vantage extracts and processes cannabinoids (e.g. cannabidiol) from industrial hemp and extracts from other plant and mushrooms compounds for supply to the food additive, dietary supplement, and pharmaceutical industry, as well as formulates and manufactures finished products with the extracted ingredients.
Vantage is accomplishing its mission to become the leading supplier in the plant-based wellness industry through precise, GMP-compliant, technologically advanced, and scientifically driven extraction processes.
In 2021, Vantage sought out a partner to develop a customizable, cloud-based quality management system (QMS). The company prides itself on using cutting-edge solutions for all of its processes and wanted to invest wisely in its technology to automate and enforce quality systems and processes to ensure the highest level of cGMP compliance.
With a goal to streamline and simplify the quality system, Vantage was in need of a QMS technology vendor to implement a compliant quality management system for investigations, document management, training, and other activities that meet the high regulatory requirements for electronic systems.
Vantage’s ethos is based on science, quality, and compliance employing a knowledgeable quality assurance and regulatory department that stays current with the ever-changing hemp/CBD regulations. Meaning that any solutions to its current operational process needed to meet the highest of standards.
C15 Solutions‘ eQMS is based on Veeva’s original, world-class system that some of the world’s largest pharmaceutical and CPG companies have adopted. Utilizing best practices from other regulated sectors, C15’s system has been configured specifically for cannabis and its adjacent industries, serving 60% of the top 10 cannabis companies.
Three years of aggregated data demonstrate that C15 customers obtain a return on investment (ROI) between 750-1,000% (not a typo!). Daily efficiencies demonstrate a 75% reduction in time needed for editing, reviewing, approving, and distributing controlled documents, closing quality events, and training management.
The cloud-based QMS from C15 was utilized to accomplish Vantage’s goal of streamlining and simplifying the quality processes and assuring that all production and distribution activities produce consistently high-quality products and services that meet customer, regulatory, and legal requirements.
The eQMS now applies to all aspects of the company’s commercial production activities and support functions.
C15’s solution involved all quality-related matters and all systems for controlling and assuring the safety, identity, strength, quality, or purity security of all products made at Vantage.
This includes but is not limited to the following:
- Document and change control and approval
- Equipment documentation review and approval
- Materials evaluation and acceptance
- Product release
- Administering deviation investigations and CAPA
- Supplier approval
- Record retention
- Complaints and recalls
- Quality audits
- Product quality and management reviews
Furthermore, C15’s QMS adopted by Vantage was designed and is compliant with the following regulations and guidance documents:
- Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
- Part 111—Current Good Manufacturing Practice in Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- Part 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals
- The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Quality Guidelines Q7, Q8, Q9, Q10
- FDA Guidance for Industry, Quality Systems Approach to Pharmaceutical cGMP Regulations (2006)
- World Health Organization (WHO) Annex 2 – Good Manufacturing Practices for Pharmaceutical Products: Main Principles
RESULTS & BENEFITS
C15’s automation of key processes works in tandem with Vantage’s vast experience, pharmaceutical-grade production standards, and deep manufacturing expertise, creating the ideal partnership.
Since the implementation of C15’s eQMS, Vantage has observed significant decreases in time to completion of various areas. For example, the company’s time to close investigations decreased by 85.5% when making the shift to a customized and more automated approach via C15. Additionally, in other areas like training, the electronic reminders and convenience of online SOP review have led to a greater than 95% compliance rate. Vantage has also seen a total direct cost reduction of $1,165,295 USD and obtained a total ROI of 1,780%.
“I have been working with C15 for over a year in developing our custom, cloud-based QMS system. They are very responsive to my needs and are quick to develop,” explains Darcie Moran, Vantage’s Quality Assurance Manager.
Some of the direct benefits of utilizing C15’s customizable, cloud-based QMS includes but is not limited to:
- A centralized approach to managing quality information and documentation, significantly reducing risk and liability such as fewer errors, missing documents, and document tracking
- Reduced cost of non-compliance – C15 has a leading, enhanced ability to comply with regulations demonstrating a ‘controlled state’ of operations
- Reduces the cost of poor quality and reduces the risk of recalls
- Provides more governance on mission-critical risk areas
- Improved visibility facilitates informed decision-making and effective allocation of resources to improve manufacturing processes
- Provides a competitive advantage and consistently provides assurance of continued process performance and product quality
- Positive brand perception of partnering with C15 for QMS
- Eliminates a high percentage of costs associated with printing, copying, and managing paper documents
- Serves as a baseline for compliant operations
- Provides agility during audits – better impression, document flow, and timely information retrieval
- Moves products through the supply chain faster as open quality events are tracked and resolved earlier
- Less time is spent preparing for regulatory audits, as well as fewer regulatory observations and follow-ups
- More visibility and transparency across all departments
The team at Vantage comes from a variety of GMP-regulated industries, bringing a wealth of knowledge and experience that benefits its clients. Partnering with C15 for its QMS shows that the company takes incredible pride in the products it manufactures with a strategic focus on quality, compliance, reliability, and repeatability.
The company recently filed a Drug Master File (DMF) for CBD Distillate to the U.S. Food & Drug Administration, which is a testament to Vantage’s dedication to manufacturing the highest quality CBD active pharmaceutical ingredient (API). Vantage confidentially provides the FDA with all details on facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of CBD Distillate that the regulator requires for approval of drug ingredient applications.“Vantage is a wonderful partner as the company truly exemplifies a ‘culture of quality’, says Daryl Grayson, VP of Client Service at C15. “The team understands the importance of quality management in order to deliver first-class CBD products. For this reason, Vantage demands a lot out of the C15 platform and from our C15 customer success team; and rightfully so.”