Top 5 Reasons to be UE GMP
When it comes to the United States, the legality and regulation of CBD is relatively straightforward under the 2018 Farm Bill. In the EU, however, regulations of CBD vary greatly making GMP compliance a more complicated conversation overall. Much like the FDA, the European Medicines Agency has regulations in place that regulate the use of CBD as a food or medicine product, but depending on the country itself, EU GMP compliance is widely different.
For example, while CBD is considered an illegal narcotic in Sweden, but is considered to be a novel food in Spain. These discrepancies are widespread throughout the European Union, so what is the point of putting in the effort of being EU-GMP compliant?
In this episode of extrakTALKS, Dr. Jon discuss the top five reasons to be EU-GMP in the CBD industry. Among the top five reasons in this episode are: Access to a 500M population, Taking advantage of a country by country EU market that is continuing to grow, opportunity to implement a pharmaceutical quality system that will increase the professionalism of your own company, Differentiation of your company, and Building consumer confidence in a quality product. Listen up if you are interested in tackling the opportunities of EU-GMP compliance in the ever increasing CBD market.
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[00:00] – Welcome!
[07:19] – Overview of EU-GMP
[08:27] – Top 5 Reasons for EU-GMP
[13:43] – ISO
[18:42] – Health Products Regulatory Authority
[23:44] – EU Regulation of Hemp
[31:35] – Novel Food Application Requirements
[34:50] – EU-GMP Regulations for Cannabis & Hemp
[38:44] – EU-GMP Certification
[45:01] – EU-GMP Post Certification Inspection & Coordination
[47:42] – Basic EU-GMP Requirements
[49:00] – What is a Pharmaceutical Quality System?
[50:24] – Key Elements to EU-GMPs
[51:36] – What is a Qualified Person?
[52:45] – Risk Management Process
[55:16] – Risk Assessment Tools
[56:56] – Failure Mode, Effects, and Critical Analysis
[57:10] – Risk Ranking & Filtering
[59:37] – Top Reasons Against EU-GMP
[65:11] – Final Words
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