GMP for cannabis products

Medical cannabis and products derived from cannabis have enormous potential as complements to existing treatments. The range of products are nearly unlimited and offer variations such as flowers for inhalation, oils and capsules containing cannabis flower extracts and isolated cannabinoids: going forward, cannabis product quality needs to be assured according to good manufacturing practices (GMP).

Due to various factors, Switzerland offers an attractive environment for companies developing a business model with various activities such as growing, processing and import/export. These companies find themselves confronted with GMP topics and often need external support.

For over 10 years gempex has been servicing numerous customers around the topic of medical cannabis and has successfully achieved simple to complex projects. “We often see start-ups with two or three employees, who have a lot of experience in growing and processing but lacking GMP experience. Nevertheless, it is critical to take quality standards into account in the project plan early on,” says Perry Fischer, Managing Director of gempex GmbH in Sisseln. gempex assist our clients from the first conception workshop all the way to operating approval. The measures that are addressed can differ depending on the product type and processes. We are able to provide individual support such as, an assessment of the conceptual design of facilites for clean rooms, creation of standard operating procedures (SOPs), delivering an in-depth employee training.”

GMP as such applies only to processing, but first the quality of the raw materials, the cannabis plants and/or flowers, needs to be assured with GACP (good agricultural and collection practices). This applies equally to companies that do not grow the cannabis plants themselves but purchase them, because the regulations require the assessment of suppliers for critical raw materials and service providers for outsourced activities regarding their quality capability. Here gempex provides support with audits conducted by experienced auditors.

The GMP service provider in Sisseln offers a full range of support for the topics of GMP, GACP and quality management systems. With many years of experience, the GMP experts perform fast and smart project work – formal where necessary, pragmatic where possible. The stated goal of gempex is that ensuring and documenting product quality can ultimately by performed directly by the client.