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GMP is the gold standard of pharmaceutical production. To obtain the GMP certificate, pharmaceutical manufacturers must be inspected by a national competent authority of the EU. In many use cases GMP-readiness is not really required and other quality standards suffice. GMP adds a lot of complexity to your business and often, only margins of pharmaceutical products are worth the effort.

Building a facility to be GMP compliant is an enormous exercise, but retrofitting an existing facility to GMP is far more time consuming and expensive. Therefore, it is key to understand your processes and production SOPs already before you start fitting out your premises (GMP per design, GMP per default).

To get your business ready for GMP you will need to spend a lot of time and resources on the 5 P’s: People (comprehension of roles and responsibilities), products (clear specification at every stage of production), processes (proper documentation, simplicity and consistency), procedures (guidelines for critical processes) and premises (cleanliness, equipment, calibration, qualification).

Manufacturing processes of cannabis such as trimming, drying, decarboxylation, extraction (i.e. hot maceration, solvent based, CO2), standardization and refinement (i.e. winterization) are well understood in the industry. All of these can be considered pharmaceutical manufacturing processes that are subject to GMP principles.

Suasionis’ readily available templates for all SOPs in your Quality System can be adapted to all individual business needs. Validation will be a major part of the time required. This can be accelerated by smart validation plans.

Recreational cannabis in Germany will not be subject to pharmaceutical GMP. The requirements to produce to recreational quality standards will be comparable to GMP expectations. Hence, a GMP-directed view on the business is recommended for business owners.

For in-depth GMP guidance, enabling, planning of facilities and execution of GMP principles front-to-end please contact us.