Delivering high-quality, safe, and effective pharmaceutical products carefully developed to preserve and improve the patient’s health.
Our quality policy
Sinceritas is dedicated to the manufacturing of high-quality medicinal cannabis products, starting from indoor cultivation of pharmaceutical-grade cannabis plants to incorporating active principles in final pharmaceutical products.
At Sinceritas, our quality policy summarizes the essential elements of our commitment to excellence.
Quality: Our number one concern is delivering high-quality, safe, and effective pharmaceutical products that are carefully developed to preserve and improve the patient’s health. At Sinceritas we strive for utmost client satisfaction by constant effective application and improvement of the Pharmaceutical Quality Management system and its processes.
Compliance: The quality of our products is assured through the implementation of international ISO Standards, GACP (Good Agricultural and Collection Practice), and GMP Standards (Good Manufacturing Practice) in cultivation, production, quality control, and comprehensive quality management.
The implementation of these standards ensures:
- The products’ consistent production and control in compliance with quality standards,
- Diligent monitoring of our activities as per various regulatory guidelines and continuous development
- Promoting environmental awareness as well as reducing waste throughout the entire lifecycle of our products
- Employee satisfaction: The quality of our products is the responsibility of every employee in Sinceritas. To ensure and maintain an infallible development, we provide an inclusive work environment where all employees have the appropriate education, training, skills, and experience to carry out their work competently in accordance with applicable regulations and Sinceritas’ policies and procedures.
To learn more on Sinceritas’ Quality Policy, Environment, Health & Safety at Work, please click here.
In a quality management system, all aspects of the laboratory operation, including the organizational structure, processes, and procedures, need to be addressed to assure quality.
Our Quality Control Laboratory is state-of-the-art equipped and organized according to GMP and ISO 17025 requirements.
All information reflects the complete history of sampling, in-process control, packaging, and control of the final product as per approved specifications and in accordance with the European and International standards for pharmaceutical quality. The information is legible, accurate, dated, traceable, and accessible.
Using validated analytical techniques we evaluate the quality of API, cannabis flower, standardized cannabis extracts, intermediate products, packaging materials, and final products. They are performed using qualified analytical instruments with high sensitivity, equipped with LabSolution™ software for audit trail compliant to FDA 21 CRF part 11 or EU Eudralex 4, annex 11.
Sample preparation has a significant effect on testing results. This involves the extraction of cannabinoids using a special technique of grinding and homogenization under low temperatures to preserve the loss of potency in heat-sensitive samples. Then SPE column method is used to obtain clean extracts for instrumental detection. When the clean extract is loaded into an instrument for analysis, it will accurately represent the complete molecular makeup of the original solid sample.
We use the following methods and techniques to perform our analytical works:
- Microscopic evaluation of the cannabis plant
- Particle size analysis and distribution
- Qualitative and quantitative determination of cannabinoids in cannabis flower and extracts using high-performance liquid chromatography with a diode array detector
- Terpene comprehensive chemical fingerprinting profiling by GCMS
- Impurities of the cannabis flower and extracts using high-performance liquid chromatography with a diode array detector;
- Water content using Karl Fisher titrator or vacuum oven
- Mycotoxins detection by high-performance liquid chromatography with a fluorescent detector
- Residual solvents in cannabis extract using gas chromatography with a flame ionization detector
- Pesticides in the cannabis flower and extracts using High Performance Liquid Chromatograph Triple Quadrupole Mass Spectrometer and Triple Quadrupole Gas Chromatograph Mass Spectrometer
- Heavy metals and elemental analyses by Inductively Coupled Plasma Mass Spectrometer
Our microbiological laboratory is Biosafety level 2, designed and built in accordance with the highest industry standards. Equipped with appliances and instruments that are products of the latest technology, the laboratory meets the requirements of ISO 17025 and GMP standards.
In accordance with the quality policy of the company, the laboratory monitors every step in the overall production process using validated methods, which guarantees reliable products with high quality.
The microbiological analysis of intermediates and finished products incorporates:
- Microbial limits testing using a colony counting method
- Microbial identification using fluorogenic methodology for gram-positive and gram-negative microorganisms within 8 hours or less
- Antimicrobial susceptibility tests using turbidimetric method with available results in less than 18 hours
- Continuous environmental monitoring of PW water, air, process gases, contact surfaces, and equipment
The microbiological laboratory completely sterilizes the produced waste, which prevents the biological contamination of the environment.
Stability studies play an important role in the development of cannabis products.
The stability studies in Sinceritas are carried out as per ICH guidelines, for different climatic zones. The recommended storage conditions, retest periods, and the shelf-life of products are determined based on how the quality of a drug substance or product has changed with time under the influence of environmental factors, such as temperature, humidity, and light. Analysis of chemical degradation products and light sensitivity of API’s.
Stability studies are conducted on developed and existing products in order to confirm their ability to comply with the product’s previously defined specifications.
The climate chambers in Sinceritas are monitored with the AtmoCONTROL software with full audit trail compliant to FDA 21 CFR, part 11.
All production processes in Sinceritas are conducted according to the GMP Standards (Good Manufacturing Practice), in state-of-the-art grade D clean rooms, equivalent to class ISO 8. The control and monitoring of GMP critical parameters (temperature, humidity, and pressure differences) in the manufacturing and storage areas are automated using BMS (building management system) and EMS (environmental monitoring system).
The production of active pharmaceutical ingredients (APIs) is performed with modern, automated manufacturing equipment and validated operations controlled with software that guarantees data integrity according to the GMP standards, EU Eudralex 4, part 11, or FDA 21 CFR, Part 11.
Sinceritas procures all production ingredients from previously qualified suppliers/manufacturers. Before utilizing them, we analyze all ingredients to determine their identity, potency, impurity, and microbial purity. Throughout all production processes, we conduct and document continuous in-process control in order to maintain all the important parameters.
We utilize innovative technology in the extraction of active components from plants, purification, and fractionation processes. By utilizing different processes such as the trimming of wet cannabis material, drying to a moisture content of ≤ 10 %, and milling of the dried cannabis material to the desired particle size the material is prepared to be processed using a Supercritical fluid extraction machine. The extraction machine that we use is fully automated which is essential for a high repeatability extraction run by one of the most powerful hardware available. As a company, we are environmentally friendly-oriented and the way in which we extract our raw materials is unaggressive and without any harm to the environment.
With this, we not only have the technical ability and knowledge to extract every single plant compound, but we can also selectively remove any other unwanted compounds and impurities using GMP compliant state of the art machines. This gives us the ability to produce pharmaceutical-grade cannabis extracts that will suit the needs of our clients.