Good Manufacturing Practices (GMP) are minimum requirements for producing safe products in the food, dietary supplement, and pharmaceutical industries. Over the past year, cannabis companies are starting to see the light at the end of the regulatory tunnel. GMP will be the standard for the cannabis industry as legalization continues to gain support across the country as more states legalize adult use programs. It is all but inevitable that federal legalization will happen in the not too distant future. That is all well and good but what exactly does GMP mean for the cannabis industry?
Before we can apply GMP to the cannabis industry we first must understand good manufacturing practices and their concepts. According to the International Society of Pharmaceutical Engineers, “Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.”
Foundational Elements of GMP System
- Validated Supply Chain of Vendors
- Robust Facility Controlling Process Risks
- Verifiable Process and Product Specifications to Define Quality
- Validated Methods to Assess Critical Control Points
- Capable Staff to Manage and Operate
- Quality Management Systems Documentation
“ ISPE further elaborates “GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.”
In the next article we will explore what it means to have a validated supply chain. Contact firstname.lastname@example.org for questions or more information to bring your cannabis business into GMP compliance!