CBD, Cannabis and Hemp GMP

The cannabis industry is rapidly developing and there is a significant interest in the implementation of Cannabis CBD and Hemp GMP (Good Manufacturing Practice) from manufacturers. GMP is the mandatory quality management system enforced and mandated by the US Food and Drug Administration (FDA) for producers of pharmaceuticals, medical devices, foods, beverages, dietary supplements, and cosmetics. In the United States, GMP regulations for Good Manufacturing Practices are outlined in Title 21 CFR. 

GMP implementation and certification is paramount in maintaining a competitive advantage for cannabinoid related manufacturers like hemp extraction facilities. There are different versions of cannabis GMP and hemp GMP depending on location. For example, the quality management system for the Canadian cannabis industry is GPP (Good Production Practice) and Europe has established regulations for the CBD, Cannabis, and Hemp industry called EU GMP. However, the United States has not yet done so at the federal level. In the US, the requirements are regulated locally by the individual states

GMP AND FDA REGULATION FOR CANNABIS CBD HEMP AND THC

In the United States, the FDA sets standards through the Code of Federal Regulations (CFR) and carefully monitors the manufacturing practices of these products including their

methods, facilities, and controls used in manufacturing, processing, and packaging to ensure that their products are safe, pure, and effective. Since the cannabinoid industry is widely unregulated at the national level, no guidelines have been developed by the FDA about the Quality Management System requirements or GMP for the manufacturers of CBD (Cannabidiol). However, it is only a matter of time before the FDA regulations for this industry are in place. It is for your competitive advantage to be proactive and have the GMP certification in place so that you will be ready and in compliance when the FDA regulations come into effect.

Having a GMP certification in a statement to your customer, competitors, and the general public about your manufacturing practices shows your commitment to the highest level of health, safety, and sanitation standards. It clearly distinguishes the quality of your products from your competitors and other CBD brands.

GMP AND ISO 9001 FOR CANNABIS INDUSTRY

It is convenient and cost-effective for the cannabis industry to integrate Cannabis CBD and Hemp GMP and ISO 9001 Quality Management Systems together. Both GMP and ISO 9001 cover a lot of areas, such as requirements in terms of documentation of a firm’s processes into standard operating procedures, staff training, traceability, manufacturing area requirements, risk management, etc. 

Implementing and integrating multiple quality management systems like GMP and ISO 9001 have many advantages. It can enhance and credibility of your company, avoid developing and maintaining multiple lists of quality management system documents, and helps you increase your market share by expanding your market reach to other countries outside of the United States.

GMP IMPLEMENTATION PROCESS FOR CBD, CANNABIS, AND HEMP INDUSTRY

Our GMP implementation process for Cannabis, CBD, and Hemp industries can save you money, time, and other valuable resources. Our unique and step by step process can be tailored to your unique needs and can be implemented without disrupting the day to day operations of your business. Our highly specialized and flexible consultants can fast-track the implementation of the Cannabis Industry GMP cost-effectively and within your required time frame. Our Cannabis CBD and Hemp GMP implementation process includes:

• GAP analysis of your existing Quality Management System related to requirements of Title 21 CFR 111.
• Developing documents such as quality manual, procedures, forms, and templates.
• FDA GMP awareness training
• Review of your Standard Operating Procedures (SOP)
• Implementing a well-documented Quality Management System throughout your organization.
• Internal Audit identifying non-conformities related to Title 21 CFR 111 requirements.
• Management Review Meetings
• Corrective and preventive actions /Root cause analysis addressing non-conformities.
• FDA audit support
• Closing of any non-conformities found by (FDA will issue an FDA 483 form with observations)

QUICK LINKS