With more people becoming regular consumers of cannabis-derived products, the quality and safety of cannabis products have become a top priority. Following this, several states have enacted new regulations that require comprehensive testing of tetrahydrocannabinol (THC) and cannabidiol (CBD) products by state-accredited laboratories. Apart from this, many states have legalized cannabis for both recreational and medicinal use.
QA/QC Processes for Cannabis Testing Laboratories
Quality Assurance (QA)
Quality assurance is critical for cannabis testing laboratories to assure the safety and efficacy of cannabis products. Firstly, a cannabis testing laboratory needs to adopt a regulatory compliant environment. ISO/IEC 17025 accreditation plays a significant role in helping cannabis testing laboratories achieve quality assurance. Quality assurance minimizes risks and maximizes adherence to proper procedures, resulting in reliable test results by preventing inaccurate laboratory processes.
Quality Control (QC)
QC is important to assure accurate and precise testing by cannabis testing laboratories. Cannabis testing laboratories are required to maintain quality control to demonstrate that their results are reproducible, reliable, and defensible. For effective quality control, quality control samples shall be analyzed in the same manner as test samples in order to validate test results. QC also supports the validity and reproducibility of test results and determines potential anomalies in the results.
Cultivators, manufacturers, and distributors need to ensure the quality and safety of cannabis products to build consumer trust. The CBD/THC tests are done by cannabis testing laboratories to determine the levels of CBD and THC. Cannabis testing laboratories also perform tests for residual pesticides, contaminants, such as heavy metals, microbes, etc. While processing each sample batch, cannabis testing laboratories must use a standard QC sample and process it in the same manner as the test samples. Some of the QC samples used by cannabis testing laboratories are a method blank, matrix spike, laboratory fortified blank, laboratory fortified blank duplicate, a matrix spike duplicate. It is important to record QC test results and to make them available to customers whenever requested to substantiate the test results of actual samples. This helps boost customers’ confidence in the test results of samples submitted by them. If QC results fall outside the acceptable ranges, then analysis of samples should be repeated to ascertain the accuracy of test results, and appropriate corrective measures should be taken to prevent its recurrence.
It is always important to maintain consistency in laboratory operations. Cannabis testing laboratories must streamline and automate QA/QC processes to enhance efficiency and to avoid missing any crucial step. To reduce the burden of daily tasks and activities necessary to deliver quality results, it is imperative to create dependable methods and secure them into an established workflow. Manual data handling and monitoring of QA/QC processes become difficult for laboratory personnel as it is time-consuming and error-prone. Cannabis testing laboratories must have pre-defined standard operating protocols (SOPs) for processing QC samples, recording their results, and initiating necessary actions to correct non-conforming processes. Extensive QC process controls and complete data review are required to identify and minimize errors, and to track deviations from SOPs.
Role of LIMS for Easy Management of QA/QC Processes in a Cannabis Testing Laboratory
A LIMS plays a crucial role in managing samples, analytical testing data, and also in ensuring proper calibration and maintenance of analytical instruments before use. It helps manage quality control samples and their test results in cannabis testing laboratories and automatically compares the QC results with the test results of the actual samples. A LIMS accounts for every gram of each sample from receiving, testing, to disposal. State regulatory authorities have set an acceptable threshold limit beyond which a LIMS automatically flags unusual test results. This helps laboratory personnel to readily identify incorrect or abnormal experimental values and re-test the samples if required.
A LIMS is a crucial tool for automation. A Cannabis LIMS helps in automating QC testing workflows, maintaining SOPs (Standard Operating Procedures) for processing and testing QC samples, and recording training of staff involved in analyzing QC samples and generating QC charts. Using a LIMS can help cannabis testing laboratories deliver high-quality results consistently to their customers. Achieving compliance with safety regulations is also necessary for a laboratory to maintain QA/QC standards.
A cannabis LIMS helps in the following ways:
- Reduces manual errors and data redundancy
- Enables fully automated data exchange with analytical instruments, such as HPLCs, GC-FIDs, mass spectrometers, through instrument integration
- Automates validation of test results, including QC results
- Generates custom CoAs (Certificates of Analysis)
- Ensures data integrity through seamless instrument integration
- Supports internal auditing practices
- Ensures timely calibration and maintenance of analytical equipment
- Supports good documentation and record-keeping practices
- Helps follow GMP requirements to meet quality standards
Conclusion
Cannabis testing laboratories face several operational challenges such as managing cannabis samples, keeping an account of each gram of sample, managing multi-analyte tests and QC test results, meeting regulatory guidelines, on a daily basis. All these challenges strain the effective management of the QA/QC processes. A LIMS can increase the efficiency of cannabis testing laboratories and reduce procedural errors by automating workflows, enforcing SOPs, and by strong process controls. Through instrument integration, a LIMS ensures seamless data exchange with analytical instruments, preventing manual errors, and maintaining data integrity. A LIMS helps manage quality control test results and compares them with the original test results to identify interferences that may compromise the validity of analytical results. It helps in including QC results in CoAs to support the validity and accuracy of sample test results. Thus, a LIMS software plays a crucial role in cannabis testing laboratories by managing, streamlining, and automating QA/QC processes.