GMP standards For the manufacture of medicinal cannabis products

As we know, in the production of food, medicines, drugs, etc., good manufacturing practices are essential to obtain the required quality standards if what we want later is to launch our products to the market. GMP (Good Manufacturing Practice) or Good Manufacturing Practices (BPF) They have a series of rules and guidelines to follow in the production process that allow us to achieve quality indices and optimal safety in each process. Cannabis-based products are no exception, so in their production, both GMP standards and the law in relation to medicinal cannabis will have to be complied with.

Let us now talk about the medicinal sector and, specifically, about the cannabis production for this purpose. According to the JIFE (International Narcotics Control Board) Spain will shoot its production in 2022 until it reaches 6,000 kilos of cannabis for medicinal purposes. This supposes that the Narcotics Control Board expects that production will be given ten times greater than in the previous year, in which some 600 kilos produced were recorded. The truth is that research on medicinal cannabis is hopeful and every day the use of this drug becomes more common.. 

This is why this new industry is being given wings in different parts of the world, which seeks investors and good practices, which are based on a series of processes that guarantee their quality and minimize the risks in any pharmaceutical production. In fact, in Spain, the law allows medicinal cannabis, so it is natural that also in this country there are more and more companies that want to produce cannabis-based products. This is precisely what gives rise to the very high production expectations of the International Narcotics Control Board.

As in any manufacturing process, there are risks that can affect the final product and that should keep us alert. The basic principle of GPM is that quality control must be integrated at all stages of the process and this, of course, also applies to the production of cannabis products. The regulations take into account:

• the staff. It is essential to have a qualified staff to whom we must offer continuous training. The process of good practices depends entirely on people, so taking care of this point is the most important thing. These teams of structured people must work with guidelines previously defined in a program to be strictly followed in the manufacture of cannabis products and in any other sector of activity.
• facilities and equipment. the facilities of the White rooms for the cultivation of medicinal cannabis and the processing equipment we have must be qualified and qualified, calibrated according to the regulations by which we are governed in each part of the process. The company must have validated and correctly documented facilities. In short: work in an appropriate environment, with the optimal levels of cleanliness and hygiene, correct lighting, ventilation and temperature, without forgetting the importance of the correct conservation of raw materials.
  
• Documentation. If what we want is to obtain a quality certificate at the end of our production process, the key is, not only in a correct monitoring of the process, but also to have a clear and unequivocal record of the resources and means that we have and that can be accessible at any time for all the staff. Good documentation is synonymous with guarantee, key to achieving compliance with good practices, both in the manufacture of cannabis-based products and in any other sector.
  
• Quality controls. These controls must be present in each decision-making and, especially, in the manufacture of products for human consumption, such as cannabis products. We must keep in mind that, depending on each product and what they are going to be used for, we can apply different production standards. Therefore, the applicability of the GMP guidelines may vary depending on the nature of the process.
  
• Outsourced activities. As is normal, each company when it comes to making its product is related to other companies from which it needs to subcontract a service or demand a product. It is a matter of the manufacturer to ensure that these companies and their products also follow the GMP regulations, thus avoiding that they do not affect the quality of our products. Therefore, we must have an internal inspection system, which provides us with the security that we have the required degree of involvement with respect to good practices.

In any case, these GMP standards are mandatory and must be strictly followed, being the manufacturer that must ensure that they are applied correctly, with the required safety, efficiency and quality. In this way, it is ensured that the products based on medicinal cannabis not only comply with the cannabis law of Spain, but also have been produced in a correct way and that, therefore, its consumption by the public is safe. Only in this way will we obtain the optimal standard of compliance with international quality.