Improving the SOP of managing controlled CII substances in the laboratory from receiving to discarding

Abstract

As a contract manufacturing operation, the needs of our clients are our priorities. The inclusion of controlled substance schedule II to our list of products has been a challenge that we are still trying to overcome. Regulations and requirements for the management of controlled substances schedule II are very rigorous. They must be monitored from the time they arrive to the time they are disposed. A standard operating procedure (SOP) is established in order to meet regulations and have a clear and consistent procedure to manage CII substances as required. Nevertheless, flaws and gaps are found in the current SOP and it is mandatory to improve the procedure to meet regulations. The DMAIC tool was used to identify the deficiencies in the process. An improved process was suggested after analysis phase. The SOP was revised, and the improved process was placed as a new revision after giving training to the corresponding personnel. Key Terms ⎯ Controlled Substances CII, DMAIC, Six Sigma, SOP.