To explain what exactly it means to have Good Manufacturing Practices (GMP) is to ensure the consistent quality and safety of products by focusing on five key elements, which are often referred to as the 5 P’s of GMP—people, premises, processes, products and procedures. GMP describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at European Union (EU) level.The ICH direction Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredient (API) is intended to provide guidance regarding GMP for the manufacturing of (APIs) under an appropriate system for managing quality. This regulation was finalized under Step 4 in November 2000 and is intended to provide guidance regarding GMP for the manufacturing of APIs under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.
So why is this necessary and a significant step for Vantage Hemp Co. to achieve compliance with world-wide regulations regarding the distribution of CBD extracts in the EU?
It’s a necessary step to continue on their forward progress in CBD extraction and becoming a more recognizable brand and company by increasing their profile in the EU market. It’s important to create a foothold and identity in the EU as it continues to be a thriving market for hemp and CBD consumer spending. The EU is more liberal when it comes to the legal sale of CBD and is more readily accessible than any other market around the world. “This is an important step for Vantage Hemp Co. to provide high quality CBD extracts for the EU. There continues to be a strong demand for CBD extracts in the EU market that are of the quality produced by Vantage Hemp Co. We are always looking for ways to expand our foothold in the EU market and to increase our visibility in the North American, European, Australian and South American markets.” – Deepank Utkhede, Chief Process Biochemist of Vantage Hemp Co.According to the Orian Research Group, the current market size for CBD in Europe is approximately €450 million representing 31% of the global CBD oil market share, second only to North America with a market share of 40% and the European CBD market is projected to be worth at least €1.5 billion by 2023.
Deepank Utkhede continues:
“As we proceed down the path to achieve compliance with world-wide regulations, we are positioned to become the leading global supplier of CBD extracts while continuing to maintain 100% dedication to premium quality, science-driven consistency, sustainability, transparency, and positive, trustworthy relationships with our clients and community.” Another important factor for Vantage Hemp Co. is expansion of their foothold into the EU market is the potential benefit to North American producers due to the US market operating on a state-by-state basis. Since cannabis is a fairly new market, and is not legal nationwide in the US, federal agencies have not yet developed national standards. The FDA establishes national Good Manufacturing Practices regulations for a wide range of products including foods, human and veterinary drugs, vaccines, medical devices, radiation-emitting electronic products, cosmetics, dietary supplements, and tobacco products.
Looking ahead and continuing to grow
Vantage Hemp Co. has a clear vision to become a world-wide leader in CBD through hemp extraction and acquiring EU GMP compliance will solidify that goal. This stepping stone will provide a stamp of approval for increasing their brand as a trusted and reputable global CBD extracts producer. It’s an essential step to exporting CBD to European markets. This compliance will enable Vantage Hemp Co. to continue in their global growth strategy, and make their products accessible in the EU market while building international credibility and advantage when it comes to exporting high-quality CBD extracts to Europe.Vantage Hemp Co’s vision of continually striving to become the leading CBD extracts supplier while maintaining a 100% dedication to premium quality, science-driven consistency, sustainability and transparency, and positive, trustworthy relationships with partners and community will truly resonate with North American producers who also pursue EU-GMP compliance.“We always strive to be the leader in our industry and want to help other North American companies that share our same vision and goals with getting their name and CBD products more visibility and recognition in the EU and global market.” – Deepank Utkhede.
Laura Eder has more than 19 years of experience in the life-cycle management of pharmaceuticals and medical devices. She has had her Regulatory Affairs Certificate (RAC) since 2012. Through her time spent in the world of pharmaceuticals, she has developed a comprehensive knowledge and understanding of FDA regulations, as well as worldwide regulations. She has created an outstanding relationship with the FDA's Office of Prescription Drug Promotion (ODPD) for over 15 years submitting websites, commercials, and promotion materials without issue. Early in 2019, she transitioned into the CBD industry as the Regulatory Manager where she helped to guide the company through several significant regulatory milestones. Leading a team to complete ISO 9001:2015, as well as GMP 111 (dietary supplements) and 117 (food) certifications in record time. The audits with SGS were completed in just three months due to her leadership skills, experience and understanding of what would be needed for this industry. Following that Laura started her own consulting business for a short period before joining Vantage. Once she saw the opportunity at Vantage where she could use her pharmaceutical knowledge and experience in the CBD industry she knew it was the perfect relationship. Since being at Vantage Laura has again completed another successful audit. The annual surveillance audit this past February 2022 which was conducted by SGS at the pharmaceutical level and no findings was the final outcome. Laura is looking forward to moving the CBD industry forward ethically and legitimately with transparency to government agencies such as the FDA.