@article{Cocovska_Janevik-Ivanovska_2022, title={CRITICAL EQUIPMENT QUALIFICATION PARAMETERS AFFECTING THE HOMOGENIZATION PROCESS OF MEDICAL CANNABIS SEMI-SOLID PHARMACEUTICALS}, volume={54}, url={https://ikm.mk/ojs/index.php/kij/article/view/5626}, DOI={10.35120/kij5404669c}, abstractNote={<p>The medical cannabis has been used for many of years for medicinal purpose, in different pharmaceutical<br>formulation, mostly as a magistral preparation for the relief of pain in cancer patients or chronical painful diseases.<br>Over than 540 substances were found from which more than 100 that have been found to be cannabinoids due to<br>their similar chemical structure. The component with the most psychotropic action is Δ9 -tetrahydrocannabinol (Δ9 -<br>THC), and the major non-psychoactive ingredient is cannabidiol (CBD). Δ9 -tetrahydrocannabinol firstly was<br>isolated in 1969 by Robert Mechoulm and Yechiel Gaoni. In 2003 World Health Organization put Δ9 -<br>tetrahydrocannabinol in Schedule IV of the convention. Several therapeutic indications relate to the Δ9 -THC and<br>CBD as analgesia, inflammatory and neurodegenerative diseases, and many other cases. In some studies, there are<br>reported safety concerns about the registered side effects of Δ9 - THC as a psychoactive. For that reason, the legal<br>usage of cannabis for medicinal purposes and for recreational use is regulated differently. The most relevant<br>explanation is related to the not enough sufficient results and data obtained from the pharmacokinetic studies and<br>research in pharmacological behavior. Extracts of cannabis was used from many years ago. Nowadays in<br>pharmaceutical industry as the development of technology there are many dosage forms in where extracts,<br>cannabinoids, flower are used. Medicinal cannabis products can come in many different forms, including capsules,<br>drops, chewable, creams, crystals, flower, lozenges, oil (most common), oro-mucosal sprays, tinctures and many<br>more. Also, there are synthetic analogs to nature cannabinoids in pharmaceutical market. In this study will be<br>discussed about production of semisolid pharmaceutical forms obtained from medical cannabis. They are produced<br>in pharmaceutical grade equipment, high-pressure homogenizer mixer. In this study it will be discussed about the<br>process of equipment qualification. Firstly, by the user requirement specification, design qualification protocol was<br>approved. Then factory acceptance test was performed in production site of equipment and site acceptance test was<br>performed in costumer’s site. Then installation qualification protocol was look through and then operational<br>qualification protocol also. All the qualification protocols were approved by both sides. In different qualification<br>protocols, different tests were performed, and they are explained separately. During the qualification process, there<br>are considered some of the parameters which later during the production process can affect in the quality of finished<br>products. These parameters are called critical process parameters and accent will be put on this process parameters<br>that are with a critical effect on quality of the final products. This critical process parameters were considered and<br>concluded from qualification protocols where all the parameters that can affect quality of the product were<br>separately examine.</p>}, number={4}, journal={KNOWLEDGE - International Journal }, author={Cocovska, Ivana and Janevik-Ivanovska, Emilija}, year={2022}, month={Sep.}, pages={669–675} }