GACP – GMP Cannabis Consultants in the Cannabis Industry
Great GACP – GMP cannabis consultants are hard to find in this high growth cannabis industry which seems to be expanding each month. There is an enormous amount of paper work that needs to be completed to obtain a Good Agricultural and Collection Practices (GACP) approvals and national cultivation and production licenses; as a medicine a company will need a Good Manufacturing Practice (GMP) license issued by a national competent authority like the US FDA, UK MHRA or the Australian TGA. One way to ensure a rapid path to obtaining these licenses is by investing in the GMP team that will get you there without cutting corners and without setbacks.
What makes a good GMP Cannabis Consultant and what are the traits you need on your team?
GMP Cannabis Consultants need to be able to successfully navigate the project through the required project phases ensuring compliance along the way. A good GMP Cannabis Consultant for the cannabis industry will strive for a manufacturing process flow that has quality built in at every step. The basic principle of regulation is that the quality of the product cannot be tested in the final product and must be integrated into the whole product lifecycle from incoming material up to distribution. The Consultant will have previous experience within highly regulated environments, bringing with them the understanding that continuously high quality is the most important aspect of any good product, be that from the pharmaceutical, medical device or cultivation industries. The correct facilities need to be in place to build a quality product. The consultant can review current facilities or recommend the necessary facilities required for GMP. These facilities incorporate all aspects of the cannabis manufacturing plant – from adequate premises and space, suitable equipment and services, correct materials, containers, labels to the storage and transport of the finished product.
The consultant recognizes that all critical processes need to be validated and that all changes are managed in accordance to a strict change control process that is implemented. They can author and edit the necessary documents required to have a complete Pharmaceutical Quality System including, but not limited to, any forms, work instructions and standard operating procedures across a range of areas – utilities, cleaning, waste disposal, test methods etc. For the cannabis industry the GMP consultant provides a system that:
- ensures all cannabis batch information is readily available in an easily comprehensible and accessible form
- allows for any recall of cannabis product from sale or supply if needed
- monitors complaints, investigates causes and implements controls to prevent re-occurrence
- guarantees that operators are trained to carry out procedures correctly
A key benefit of contracting a GMP Cannabis consultant from a large consultancy firm is that they will have a team with expansive knowledge at their disposal. They will have the ability to solve problems as they arise quickly and efficiently with experts in areas such as architecture, engineering and ex-regulators on hand to provide both guidance and direction. It is a massive advantage to have experts in GACP and GMP and facility design involved at an early stage to unsure a smooth journey to obtaining the necessary licenses.