QSI

Given the rising consumer concern and the growing complexity of legal requirements and quality standards in the food sector, reliable analysis of food and pharmaceutical products is of paramount importance today. When it comes to cannabis products, these analytical procedures are critical to measuring the potency and quality of products required to meet consumer demands and diverse regulations across different nations and states. One company that has made an indelible mark in the field of food quality control is Bremen-based QSI—Quality Services International GmbH. Founded in 1954 as a laboratory for honey analysis, QSI has expanded its portfolio of analyses over the years. In 2017, when the use of Medical Cannabis was legalised in Germany, QSI has started testing cannabis and hemp containing products, since the very first day, as the first laboratory in Germany. “Being part of the Cannabis business since it started in Europe, gives us a lot of experience which was even increased by sharing our knowledge with other Tentamus laboratories specialised on the analysis of hemp,” says Dr. Cord Lüllmann, General Manager at QSI.

Driven by long term laboratory experience, QSI leads the area of instrumental analysis and is equipped with state-of-the-art methods and instruments. The company is highly dedicated to herbal drugs such as hemp/cannabis. “One of the biggest challenges our clients are facing is the complexity of legal regulations in the food and pharma sector. d9-Tetrahydrocannbinol (THC) is the psychoactive substance in Cannabis sativa and thus falls under the regulations of narcotics law. However, there are no legal limits for THC in food, only Acute Reference Dose (ARfD) for the evaluation of food safety,” explains Annika Wessels, Business Manager Food. Because of this very complex topic, QSI combines analytical knowledge with regulatory consultation. “We can help clients in case they get a legal claim by authorities. Our authorised experts for the examination of official cross-checks are allowed to test and evaluate samples taken by authorities,” Annika notes.

QSI can offer analyses for food according to ISO 17025, as well as GMP-certified analyses, for example, for the strongly regulated market for Medical Cannabis. The company has implemented a variety of methods from pharmacopoeia monographies for the quality control testing of cannabis products such as flowers, extracts, CBD or Dronabinol.

Dr. Johannes Junemann, Head of Quality Control, comments, “The most important analyses for product safety and quality are the analysis of Cannabinoid profile, Terpenes, Microbiology, Contaminants and Residues, such as Mycotoxins, Pesticides or Heavy Metals. Legal requirements for those parameters vary from country to country.” To this end, the Tentamus Group has experts located in Europe, the U.S., Asia and Israel and can thus advise clients on different market requirements.

Due to its broad method portfolio and a large variety of analytical equipment as well as highly specialised partner laboratories within the Tentamus Group, QSI is able to conduct all analyses required for the release of cannabis within the scope of their GMP certification for quality control. It is a great advantage for QSI’s clients that they have only one competent contact person at QSI, and the company takes care of all analyses and compilation of all results. In this respect, QSI’s clients also benefit tremendously from the fact that QSI also holds its own manufacturing authorisation. This allows the company’s qualified person (QP) to be able to perform batch release for cannabis in addition to quality control testing.

In most cases, these samples need to be analysed in a very short time. Especially if a product is out of stock or the client has a tight delivery schedule, or a claim by customers, fast and reliable testing and consulting is essential. In order to meet this requirement, QSI has direct and competent contact persons for its clients, and its turnaround time for analyses is much faster than the industry standard, especially when its express service is used. The quality control of Medical Cannabis also benefits from these optimised and lean processes without compromising the high quality of the analytics. In combination with its in-house QP, this allows QSI to offer its customers the entire release analysis in just one week.

The Tentamus Group already has more than 80 laboratories worldwide. For hemp analysis, there are locations in the U.S., Europe, Israel and Asia, all combining the knowledge of different countries regulations. QSI’s state of the art methods and instruments are updated regularly. As an example, the company has already updated its analyses to the latest technologies like Liquid Chromatography-Mass Spectrometry (LC-MS/MS), High Resolution Mass Spectrometry (HRMS) and Nuclear Magnetic Resonance Spectroscopy (NMR) and keeps an eye on further new technologies.

Through their vast analytical expertise and cutting-edge instrumental analysis, QSI also contributes to frontier research and develops and validates methods tailored to the needs of their clients.