Accreditation of an analytical method for the determination of tetrahydrocannabinol in oil

Abstract

Accreditation of testing laboratories is proof that the laboratory operates competently and generates valid test results thereby promoting confidence in the quality of testing services. To obtain International Organization for Standardization (ISO) 17025 accreditation, the laboratory has to meet the general, structural, resource, process and management system requirements of the ISO standard. An ISO 17025 mandatory documentation checklist was developed through a review of the ISO standard, to obtain an all-inclusive list of documentation required for the accreditation of a testing laboratory. Review of the guidelines issued by the National Accreditation Board-Malta was carried out to identify additional mandatory documentation required during the application phase. A Quality Management System, compliant with the ISO 17025 standard, was developed for analysis of tetrahydrocannabinol (THC) in cannabidiol (CBD) oil at the Pharmaceutical Synthesis and Technology laboratory at the Department of Pharmacy at the University of Malta. The Quality Management System was developed according to the mandatory list of documents for ISO 17025 accreditation and is comprised of a Quality Manual, standard operating procedures (SOPs), forms, risk assessments, policies and declarations. A review of already existing laboratory documentation was carried out to ensure compliance with the ISO 17025 standard. The format of the quality manual was developed according to the five main sections of the ISO 17025 standard and amended according to the scope of the laboratory. The manual outlines the procedures and practices in place at the laboratory and is inclusive of the list of quality management system documentation. Risk assessments were developed to determine the impartiality of laboratory activities and calibration intervals of equipment used in the analysis of THC in CBD oil. Equipment utilised in the analysis of THC was calibrated by ISO 17025 accredited calibration laboratories, according to the calibration interval established though the equipment calibration risk assessment. SOPs were set up for the management of: corrective and preventive actions; complaints and feedback; internal audits and risks and opportunities; and improvements. Currently there are no local ISO 17025 accredited laboratories for the analysis of THC in oil. Accreditation of an analytical method to determine THC in oil within this university research laboratory will contribute to the industry by supplying accurate and reliable testing of cannabis products, to ensure that the products meet the expected quality standards.