Testing Labs
CANNASEN® Products Are Quality Tested
Our CBD products have a good safety profile.
We take control and testing very seriously. We and our collaboration partners spend extensive resources on quality control. We always strive to deliver a CBD product of high quality and consistency.
We use modern equipment in the field and our Cannabis undergoes in-depth tests following the GACP procedure to ensure that it is safe, healthy, and complies with our high-quality standards.
The crystals used in our products are evaluated and the composition tested with the use of scientific techniques and technologies, such as HPLC and NMR. Following the CoA, we use the NMR for identification, the HPLC for the quantification of cannabinoids and to make sure that no pesticides or heavy metals are present.
All our subcontractors’ production phases follow:
CANNASEN products are developed under high-quality standards and produced and delivered under GACP, GMP, HACCP, ISO9001, ISO 10993, and ISO 13485, in this way, we ensure that only the best is offered to our customers.
1. GMP
Goods Manufacturing Practice.
Instructions for all phases of the production cycle) which are based on a solid integrated quality system and risk management procedures.
2. ISO
International Organization for Standardization.
That is quality regulations ensuring safety and quality precautions for consumers.
3. ICH
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
4. HCCAP
Hazard Analysis and Critical Control Points
Ensures that the quality and safety of our food supplements are appropriate and consistent, and in compliance with safety, quality, and efficiency requirements.
It is one of our goals to help raise the general level of quality in the Cannabis industry by being a front runner and role model.
Testing
Manufacturing, Packaging, Storage & Distribution.
Extensive tests and control including in vitro skin-sensitization test, in-vitro efficacy test, skin-irritating test, and cytotoxicity test, are performed on all CANNASEN CBD treatment products.
All raw materials undergo a quality assurance check to ensure consistent quality.
Production is only carried out after validation of the manufacturing and testing processes.
The storage conditions are monitored and documented.
Risk Management
Testing of Medical Device Products.
Risk analysis is the systematic use of available information to identify information to identify hazards and to estimate the risk. The risk analysis on our treatment products is based on ISO 14971.
Together with our partner laboratories, we test our medical device products for a biological evaluation in accordance with ISO 10993-1:2018. Our medical devices also follow relevant parts of the ISO 10993-series and extensive risk assessment. Biological evaluation is part of a risk management process conducted according to the requirements of ISO 14971.
Market Monitoring
We monitor our medical devices products by performing post-market surveillance (PMS). PMS is implemented to actively and systematically record, analyze, and gather relevant data about a medical device’s quality, performance, and safety throughout its entire lifetime.
PMS uses a variety of different ways to monitor medical device safety such as spontaneous reporting databases, prescription-event monitoring, electronic health records, patients’ registries, and record linkage between health databases.
Our products comply with European Directive 93/42 / EEC on medical devices (MDD) and are in the process of updating according to Medical Device Regulation (MDR). We provide compliance and maintenance of quality-assured production and corresponding quality management for all processes. Our quality management system (QMS) is designed according to ISO 13485.
Products filed under MDD as a class I will, with the new MDR, be lifted to a class IIa. The intention of replacing MDD with a new MDR is to improve the safety, reliability, and quality of medical device products.
Product Release
A Qualified Person (QP), a person responsible for regulatory compliance (PRRC), and a responsible person (RP) ensure that no products are released to the market without approved quality assurance and validation.