Read more about “Good Manufacturing Practice“ of medicinal products

GMP: What does Good Manufacturing Practice mean?

GMP regulations have an important role within the quality assurance of medicinal products to ensure the safety of patients. EU GMP is also essential for the production of medicinal cannabis.

GMP means “Good Manufacturing Practice” and is defined by the European Commission. The EU GMP guidelines used to guarantee the quality of pharmaceuticals and active ingredients as well as cosmetics, food and animal feed are laid down by the European Commission.

The guidelines aim to identify and eliminate risks to product quality at an early stage. To this end, for example, hygiene standards are defined and the use of trained personnel is prescribed.

In pharmaceutical production in particular, quality assurance plays an important role in ensuring the safety of patients. That is why we and, of course, our suppliers are GMP-certified.

What do the EU GMP guidelines actually mean for medical cannabis?

In order to be allowed to import cannabis into Germany or to produce it in Germany, special conditions must be met during production. These conditions are also regulated by the EU GMP guidelines. Compliance with all requirements is regularly monitored by certified laboratories.

If cannabis will be imported for the first time from a supplier outside the EU, this supplier must first be certified. For this purpose, an inspection is carried out, which is then repeated on a regular basis. On site, it is checked whether defined processes, the so-called Standard Operation Procedures, are adhered to and carefully documented. The documentation is important in order to be able to retrace all manufacturing steps.

For example, the premises and equipment are inspected. Random checks in the drying rooms determine whether uniform drying can be ensured to prevent microbiological contamination.

Each grower must also ensure that there can be no contamination from fertilizers, growing media or packaging materials, and that strict regulations on the use of pesticides are adhered to.

Before the first import, each producer of medical cannabis is officially inspected for compliance with EU GMP requirements and then regularly monitored. This ensures that all processing steps are carefully documented so that all steps in the manufacturing chain can be traced.

In addition, the premises and equipment as well as the drying rooms are also inspected by means of defined random samples. In this way, microbiological contamination can be avoided even before the cannabis plant is grown. Attention is also paid to the fertilizers, growth substrates, pesticides and packaging materials used on site.

The EU GMP guidelines also prescribe further quality standards after cultivation. For example, there must be no interaction between the packaging and the dried cannabis flowers to ensure shelf life and preservation of the THC content. Cannamedical therefore packages at PS Pharma in Germany, which is also EU-GMP certified.

Also, each product batch must be subjected to a release analysis by a German laboratory to check whether it meets the requirements of the pharmacopoeia. For this purpose, the cannabinoid content and the microbiological condition are tested. In addition, contamination with toxins, heavy metals and pesticides is excluded.

Before the products are finally delivered to pharmacies, a qualified person must check compliance with all GMP regulations and give final approval. This ensures maximum patient protection.

Since there are GMP-defined processes in the production of cannabis, all processing steps are traceable even after the fact. In addition, high quality is ensured and the specifications prevent contamination by dangerous extenders. The EU GMP guidelines put the safety of all cannabis consumers first. In Germany, there is no other standard that offers comparable sufficient quality and protection.

The packaging process is also closely monitored within the GMP guidelines, as the product could also be exposed to possible contamination here. To rule out this risk, Cannamedical Pharma packs at PS Pharma in Germany, which is also EU GMP-certified.

The EU GMP regulations also specify it is essential that stability is not affected by interactions between packaging and cannabis flowers. At product end of shelf life, the THC content of a product must not deviate more than 10% from the content printed on the label.

Before a batch of product is finally released to the market, it must undergo a release analysis by a laboratory in Germany. To ensure the so-called specification conformity, it is tested whether the cannabis meets the requirements of the pharmacopoeia. For this purpose, the cannabinoid content and the microbiological condition are determined and contamination with toxins, heavy metals or pesticides is excluded. Only batches that pass these tests may ultimately be marketed.

In order to ensure specification conformity, compliance with GMP regulations and maximum patient and consumer protection against counterfeits and errors, this batch release must be carried out by a competent person, the Qualified Person.

A record of each dose delivered must also be retrievable for a period of several years, as the whereabouts of each dose sold must be fully traceable at all times. By complying with these GMP guidelines, patients can be sure that our products always meet the highest quality standards.

In addition, GMP quality standards form the basis for a legalized market for cannabis. Because only the EU GMP has been proven for years and thus guarantees safety – not only for the medical market, but also for future recreational consumers.