Green aspects in quality control

Abstract

Green Analytical Chemistry (GAC) is a branch developed from Green Chemistry which focuses on the development of environmentally friendly laboratory practices. The application of GAC in Quality control which is involved in all the steps required in the manufacture of a pharmaceutical product, contributes towards a decrease in the environmental impact of pharmaceutical processes. The aim of the study is to develop tools to apply GAC within Quality Control. A literature review was conducted to identify green principles and practices implemented within the pharmaceutical industry to be applied in the development of a Standard Operating Procedure (SOP) and checklist which serves as a guideline for adopting Green Laboratory practices in Quality Control laboratories. A literature review was conducted to evaluate different tools used to assess the greenness of sample preparation techniques and HPLC methods. The data collected was applied in the development of the Green Method Evaluation Scoring System (GMESS) tool which evaluated the environmental impact of analytical methods. The SOP, checklist and the novel green assessment tool were validated by a panel consisting of individuals employed in the pharmaceutical sector within the quality control department. A pilot study was performed to evaluate the developed green assessment tool, by applying it to three HPLC methods. The SOP incorporated 12 procedures for Green Laboratory Practices which included waste management, efficient water utilisation and energy consumption. The checklist was included as an Annex to the SOP and consisted of 30 statements related to the goals of GAC, namely waste, energy and water utilisation. The GMESS tool consisted of 19 categories which assess aspects related to sample handling and preparation, analytical method composition such as type of solvents and reagents used, run time, energy consumption and waste management. The developed SOP and checklist can be applied within the pharmaceutical sector to incorporate green principles within the daily activities related to Quality Control. The developed green assessment tool incorporates novel aspects such as run time, cost and temperature used which facilitates the method selection process during research and development.