Let’s use the example of the packaging for medicines. But what happens when these sustainability-driven options are not developed, or available, to meet the timelines of launching new products for patients, and what about the increasing drive to improve the sustainability profiles of existing medicines that have been, and will continue to be, marketed for many years? Industry invests significant effort into designing sustainability into the development of new medicines. The first case study looks at developing more sustainable packaging materials and reducing the size of packaging materials. This article provide insights from a CMC regulatory perspective into what is required for the pharmaceutical industry to develop and manufacture sustainable medicines which minimize the impact on the environment, utilizing two case studies based on real-world experience.
To enable changes across the industry, sustainability should be included alongside these. Global regulators are assessing drug products for quality, efficacy, and safety. In order to provide innovative solutions for embedding sustainability into products, industry requires collaborative assistance from global regulators to allow faster implementation of sustainability initiatives by using risk-based scientific approaches as described by ICH Q12 4Īnd driving harmonization across regulators globally. The industry finds itself under the spotlight of expectation to give a higher priority to sustainability initiatives. With the pharmaceutical industry being such a major contributor to the global economy and impacting the lives of so many, 3
The regulatory procedures and data requirements make it very complex to improve sustainability for launched products compared to building sustainability into new products during development.Īs such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. The implementation of sustainability-driven initiatives associated with the manufacture of medicines faces many challenges from a chemistry, manufacturing, and controls (CMC) regulatory point of view. Now there’s an additional focus: sustainability. For decades, the pharmaceutical industry has worked to transform the lives of patients by researching, developing, and manufacturing medicines for a wide variety of common and rare diseases, something that will continue for many years to come.
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