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We take the uncertainty and error out of establishing an accredited 17025 laboratory. Management System Procedures
As the United States continuously opens itself up to the multi billion dollar industry of cannabis, the need for accredited testing laboratories is imperative for this product to gain acceptance for its safety and medical benefits.
TCL’s objective is to ensure our clients always have the best quality documents such as the company “Management System Procedures” manual. Each laboratory, defined by ISO requirements, must operate at the highest level of safety based on clearly defined company procedures. TCL will establish and instill clearly defined procedures during laboratory build up and personnel training. Defined procedures assure all employees are ready to take on their new tasks at hand in a standardized manner.
Completing an accredited laboratory is a time consuming endeavor requiring industry knowledge and experience that can take from 12 months to over 18 months to implement. Since there is no standard methodology everything must be created and verified from scratch and mistakes can increase your timeline considerably. Together these factors can add up to over $2.5 million in expenses with a potential loss in time, revenue and market share.
At TCL Consulting we use our experience in the cannabis industry to develop your testing laboratory in a timely manner. We will help you avoid project delays, ensure your facility meets ISO 17025 (International Organization for Standardization), and state field sampling protocols.
Quality Management System
A crucial part of a functioning laboratory is the lab's quality manual. The quality manual specifically describes the scope of the activities of the laboratory and establishes documentation for the procedural means by which those activities are fulfilled. The Quality Manual provides all the documentation required to run the laboratory and may include: procedures, policies, forms, and checklists. These activities include: nonconformity, corrective and preventative action, document control, records management, and internal audit.
A Quality Manual is important not just for regulatory compliance purposes but also for creating an objective document that provides instruction for how functions are performed within the laboratory. This eliminates the need for "tribal knowledge" and institutional dependencies on personnel.
Management System Procedures (MSPs)
A Management System Procedures or MSPS is a set of step-by-step instructions listed in the quality manual by your laboratory to help staff carry out complex daily routines and operations. MSPS aim to achieve a standardized quality product while reducing miscommunication and failure to comply with ISO 17025:2017 industry regulations.
Validated Test Methods
Test method validation is the documented process of ensuring a test method is suitable for its intended use. Validation involves establishing the performance characteristics and limitations of a method and the identification of influences which may change those characteristics. The experimental results are subjected to statistical analysis and a series of pre-defined acceptance criteria are applied to the results. Establishing that a test method consistently produces reliable results is a critical element of assuring product quality and safety.
Management System Procedures (MSPs)
A Management System Procedures or MSPS is a set of step-by-step instructions listed in the quality manual by your laboratory to help staff carry out complex daily routines and operations. MSPS aim to achieve a standardized quality product while reducing miscommunication and failure to comply with ISO 17025:2017 industry regulations.
Cannabinoid Potency
TCL Consulting’s method and SOP for Cannabinoid analysis is accomplished using a High- Performance Liquid Chromatography (HPLC) instrument. The HPLC separates six major cannabinoids including California required analyte tests of Delta-9 THC, THCA, CBD, CBDA, CBN and CBG. Additional analytes can be included post accreditation upon request.
Pesticide Analysis
TCL pesticide analysis is accomplished through the use of a Liquid Chromatography Triple Quadrupole Mass Spectrometry (LC-MS/MS) instrument. The analytical sensitivity of the LC-MS/MS ensures detection and accurate quantification of all state required pesticide analytes.
Residual Solvent Testing
Extraction of Cannabinoids and Terpenes from the cannabis plant result in left over chemicals called Residual Solvents. Residual solvents are unhealthy for consumption and thus it is vital to verify their absence to guarantee a safe and chemical-free product into the market. Gas Chromatography (GC) is an analytical method that identifies different substances within a test sample allowing for rapid identification and quantitation of even trace concentrations of Residual Solvents.
Moisture Content Analysis
Loss on Drying (LOD) is the classic laboratory method of measuring high level moisture in solid or semi-solid materials. In this technique a sample of material is weighed, heated in an oven for an appropriate period, cooled in the dry atmosphere of a desiccator and then re-weighed. The LOD technique gives an accurate measure of moisture content if the volatile solid is primarily water. Automated moisture analyzers have been developed due to the relatively slow oven desiccator method. These analyzers incorporate an electronic balance with a sample tray and surrounding heating element. Under microprocessor control the sample can be heated rapidly and a result computed prior to the completion of the process based on the moisture loss rate known as a drying curve reducing testing time from one day to under five minutes.
TCL Consulting is equipped to accommodate your preferred method of analysis.
Water Activity Testing
Water activity is the measurement of unbounded water within Cannabis available for microbial growth. Water bound to the surface of large molecules or cell structures is unavailable to microbes while unbounded water can be utilized by microbes to continue growth. The higher the water activity value the larger the amount of unbounded water available.
Terpene Testing
Terpenes are volatile components found in the oils of plants giving them unique smells and tastes. Terpenes chemically act like Cannabinoids in that they also bind to receptors in the brain. Most Terpenes have synergistic relationships with Cannabinoids increasing their effects on the human body.
Heavy Metal Testing
As Cannabis plants grow they absorb toxic metals from soil and/or fertilizer called Heavy Metals. Lead, Cadmium, Arsenic and Mercury are all categorized as Heavy Metals. The Inductively Coupled Plasma Mass Spectrometry (ICP-MS) method provides the sensitivity to measure low levels of heavy metals without the need for increased sample preparation or additional purchase of sample introduction accessories.
Sampling
Cannabis producers can exaggerate their products’ potency through manipulation of their sampling process due to uneven distribution of psychoactive chemicals throughout the Cannabis plant. They can also deliberately select the most potent flowers of the plant by taking a sample from the part that has the greatest light exposure. Current theory states that flowers from the bottom of a plant receive less sunlight than those at the top of the plant. Thus, flowers that receive less exposure to light are likely to have lower Cannabinoid and Terpenoid content.
Sampling is the selection of a subset within a whole in order to estimate characteristics of the Cannabis product. Efficient sampling reduces the effects of producer manipulation resulting in increased sample accuracy. Despite efficient sampling Cannabis testing is still challenging due to three factors. First, Cannabis naturally varies in chemical potency both within a single plant and between plant strains. Secondly, due to its marketing as intact flower buds Cannabis cannot be homogenized without permanently damaging the un-sampled product. Thirdly, THC content is commonly regarded to vary from top to bottom of the plant or by proximity to its source of light. These factors can result in a crucial information asymmetry between the producer and the testing facility.
TCL has worked extensively on sampling procedures, method, SOP and forms. We have developed a thorough method to extract the correct amount of a comprehensive section of the provided sample. To provide maximum accuracy our design has been developed to fulfill the National Environmental Field Activities Program (NEFAP) quality for sampling.
Contact us.
Marshall Aquilino
Laboratory Operations Consultant
Tel: 925 895-9485
Email: Management@consultingbytcl.com