What is GMP?
Good Manufacturing Practices (GMP), also referred to as 'cGMP' or 'current Good Manufacturing Practices' is the aspect of quality assurance that ensures products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints.
Why is GMP important for Cannabis manufacturing?
Good Manufacturing Practices is designed to ensure cross contamination does not occur and that there is consistency in the manufacturing process along with proper documentation and tracking. It will assure that you are in compliance with regulatory agencies and are able to perform well during an audit. You will be required to explain and substantiate your manufacturing processes and provide proof that your products are safe for consumption and free of contamination from the raw material stage through the manufacturing process to the finished product.
How can a regulatory consultant assist you with your business?
Establishing the highest level of systems, documentation and traceability initially is important so as your company continues to grow your team can focus on systems maintenance and continuous improvement.
A regulatory consultant is someone who can guide you through the process of achieving compliance with your manufacturing marijuana business. Proper guidance from an experienced consultant is essential so your program is held to the highest standard from its inception. We provide the guidance to establish meticulous quality standards second to none.
What type of investment is required to embark on a compliance and regulatory program?
A compliance program requires an unwavering commitment and investment in time, energy and resources that demands a major shift in thinking, business culture and in your operations. You need to commit ongoing financial resources to support your compliance team and program to assure manufacturing consistency and compliance with all regulatory agencies. The benefits and rewards for your company in product quality and regulatory compliance far outweigh the investment.
Frequently Asked Questions
Is GMP mandatory for Cannabis manufacturers?
Since this is a new industry regulatory requirements are still evolving. The FDA cGMP 21 CFR 111 code of federal regulations for dietary supplement manufacturing came into effect June 2010 and were based on the 21 CFR 211 regulations for the pharmaceutical industry. Although a firm timeline has not yet been established the government has indicated they will be implementing guidelines consistent with 21 CFR 211 for Cannabis manufacturing.
It is prudent to start the compliance process without delay. Plan on 2-4 years to put all of the initial systems in place, build a dedicated quality team and develop a quality culture throughout your business.
When will regulatory agencies contact you to inspect your facilities?
Government agencies have the right to inspect your facility during normal business hours without prior notice. They will never contact you in advance, so you need to be prepared for an audit at all times.
Why would I want to change the way I operate my business if we already have our own systems in place and are profitable?
Now is the best time to invest in the development of your organization and stay ahead of the compliance mandates.
Is my company a good match for your services?
We will work with qualified businesses that have obtained the required operating licenses and have expressed a desire to achieve and maintain compliance with all industry, state and federal regulations.
How do we get started?
We recommend an initial consultation by phone or in person to assess your current needs and to determine how Canna Consulting 420 is best able to assist you in achieving your goals.
What is the best way to contact you?
Initially, email is the preferred method of contact.