Why is GMP necessary for medical cannabis?
In summary, the following applies to medical cannabis in Germany:
- The cannabis agency checks that only medical cannabis is available that complies with drug regulations.
- The relevant requirements, which are based on the underlying pharmaceutical law framework (including pharmacopoeias) and the corresponding GMP, GDP and GACP guidelines, must be complied with.
- Cannabis for medical purposes is also subject to the provisions of the Narcotics Act
If you want to get medicinal cannabis as a finished product, you need GMP in addition to GACP. This is a mandatory requirement!
Which production steps have to be considered?
Breeding and cultivation
growing and selection of genetics
Analytics
measuring technologys
bioavailability
monograph
Machinery and harvesting technology
machines and devices validated, GMP complient
processes, in process controls are implemented
Processes
processes validated, GMP complient
data management
Plant engineering, with drying process
facility management, (e.g. temperature, light, humidity)
safety concept
drying methods
Final release
final product development
measurements defined
neccessary documents defined
My added value for your targets!
GAP-Analysis; current status versus GMP regulations
Feasibility studies, e.g. appropriate production site, equipment
GMP expert, know how over 25 years (German regulations, FDA, Anvisa, etc.)
Well experienced in phytopharmaka
Project management/lead, e.g. creating concepts for production
sites and implementation
Define and develop processes for production under GMP
Organizational Change Management on the shop floor and Management
Huge experiences in production and scale up
Increasing efficiency and optimizing the process organization
Interim Management as General Manager, Site Head or similar
Extract from my networks
CANNABIS-NET / University of Hohenheim
1. German cannabis network
Innovative technologies with strong partner companies
Research center Julich
Top international research and development
Cooperation with the IGB-2 plant science
EUROPEAN CANNABIS ASSOCIATION
Raising awareness in the medical cannabis sector
Support in the development of standards throughout the medical cannabis supply chain
