Growing cannabis with a THC content of less than 1% is legal in Switzerland. As a result, hemp growing has been downright booming since 2016, causing prices for Swiss cannabis to plummet.
With an exemption granted by Swissmedic, growing medical cannabis (THC content ≥ 1%) is now permitted, provided it is for the purpose of medical applications, scientific research or pharmaceutical product development. But how does one obtain the approval required for growing and production in order to produce pharmaceutical products and/or active substances from medical cannabis?
Lawmakers and public authorities are currently examining a further easing of the rules for the growing and production of cannabis, also with a higher THC content. Chances of this happening are good based on the current trend! For many hemp growing operations, this could mean salvation from the downward price spiral – provided they are among the first companies to apply to Swissmedic early on to obtain approval for the production of plant-based pharmaceutical products. Because GACP-compliant growing and GMP-compliant production of medical cannabis products are prerequisites for an approval and could constitute a crucial competitive advantage.
GACP or GMP?
Pharmaceutical cannabis is covered by the Narcotics Act. This is not going to change, even after the liberalisation that is being sought. Swissmedic approvals for growing and production are therefore indispensable.
The GACP – good agricultural and collection practice – requirements have to be met for growing cannabis. Since the GACP requirements are the basis for the introduction of a quality assurance system for cultivation, they are not GMP guidelines in that sense. Rather, the objective is to ensure that the plant raw material does not suffer any loss of quality during the various processes such as growing, collection, storage and initial processing.
The production of medical cannabis products is different. GMP rules for the production of finished pharmaceutical products and active substances according to part I (pharmaceutical products) and/or II (active pharmaceutical ingredients) of the EU GMP guidelines take effect here.
Qualified GMP Consulting
Initial situation: A company is engaged in hemp growing or the production of cannabis products. Legally and without Swissmedic approval. However, future production under GACP or GMP is desired in order to obtain a competitive advantage and develop new markets. Pharmaceutical companies and pharmacies may only procure active pharmaceutical ingredients or pharmaceutical products from companies that have a Swissmedic approval - as proof of their consistent adherence to GACP and GMP rules.
This is where gempex comes in with a broad range of GMP services and always current knowledge. In combination with expertise in this field, gempex is the right contact for qualified GACP and GMP consultancy.
The approach: By precisely documenting the current situation and reviewing the business plan, gempex offers customized consulting services to obtain approval from Swissmedic. The required quality standards are identified, with consistent cost and schedule transparency and traceability. gempex assists customers in the establishment and development of a quality management system (QMS) and trains their employees in GMP matters that are relevant for inspections.
Naturally, all activities are carried out in the course of operations without impeding the day-to-day business.
Obtaining Swissmedic Approval for the Production of Medical Cannabis
gempex provides a clear plan of procedures for obtaining Swissmedic approval in the construction or conversion of medical cannabis production facilities. This plan has been successfully applied and implemented multiple times. It allows companies to obtain GMP production approval in a foreseeable time from initial planning.
gempex uses a workshop-based approach to obtain Swissmedic approval. A kick-off workshop, analysis of the current state and discussions with all parties involved in the project lead to a structured action and implementation recommendation. A quality management manual is prepared, defining and documenting the QMS. Among other things, a validation master plan has to be prepared for facilities and equipment, user requirement specifications (URS) have to be set up and the qualifications have to be performed. Detailed instructions (SOPs) are written for the quality management system based on a comprehensive preliminary analysis of the operational processes which have to set up. This is accompanied by a quality management process that ensures the standard. With templates proven multiple times and extensive know-how in this field, gempex not only delivers quality but also offers a time advantage compared to companies who do not engage a full-range GMP service provider on the way to Swissmedic approval. When you are among the first GMP-qualified suppliers, the competitive advantage is obvious.
gempex also assists with building planning and the GMP experts handle communication in the course of obtaining approval. Technical discussions with the RHI regarding the construction project can be handled. Approval applications can be requested from and submitted to Swissmedic. Inspection support, conducting external audits and the corresponding, subsequent reporting are available as well.
With this full range of services, gempex quickly and unerringly helps cannabis companies obtain Swissmedic approval for the production of plant-based pharmaceutical products.
- Current knowledge of legal requirements in the GMP field
- Access to new markets with medical cannabis
- Rapid analysis of gaps to be filled for approval
- Proven plan of procedures to obtain Swissmedic approval
- Time advantage by using proven templates
- No impairment of the day-to-day business
- Validated and traceable Supply Chain Management