Quality system
GACP & GMP
In the regulated environment, a quality management system (QMS) is mandatory. We adhere to the highest requirements for processes, traceability and digital data.
Capsule
The Quality Management System (QMS) applied to the plant in the capsule is based on GMP, and specifically on the EMA guidance for GACP. The capsule itself is manufactured, tested and monitored according to GMP and the delivery of the capsule is done according to GDP.
The capsule containing the plant is the core of traceability from the cell from in vitro cloning to the harvested biomass.
Grow Container
The Grow Container takes over the data of the capsule and the plant contained therein and continues the processes under GACP/GMP until the harvest of the plants. The cultivation process in the Grow Container is validated, the measuring units are calibrated and the data recording is validated under GAMP 5.
This rigorous adherence to high quality standards makes it easy to grow plants for pharmaceuticals, cosmetics, dietary supplements and other regulated industries.
Harvest Container
The Harvest Container takes over the data from the capsule and the Grow Container and continues the processes under GACP/GMP for harvesting the plants. The process of harvesting is thereby validated, the measuring units calibrated and the data recording validated under GAMP 5.
This rigorous adherence to high quality standards makes it easy to offer plants for pharmaceuticals, cosmetics, dietary supplements and other regulated industries.
Our QMS is designed in such a way that manual steps are eliminated as far as possible and data is compiled automatically. This manifests itself in the following functions of the QMS: