Drug delivery


sustainability Integrating


compliance


Pharmaceutical companies are increasingly looking at ways to make their drug delivery systems more sustainable in response to external pressure. But they also must comply with stringent regulations designed to prioritise patient safety. Kim Thomas asks Michaela Fuetsch, head of PT chemical and environmental legislation at Roche, how pharma companies are meeting the challenge of improving sustainability while adhering strictly to global regulatory frameworks.


P harma is one of the most heavily regulated


harma is one of the most heavily regulated sectors in the global economy. Patient safety is paramount, and every part of the development


At the same time, pharma companies, lAt the same time, pharma companies, like otherike other businesses, are faced with growing pressure from


carbon emissions, has been particularly influential in


sectors in the global economy. Patient safety is paramount, and every part of the development


and production process must meet stringent standards,


businesses, are faced with growing pressure from governments, global regulators, customers and supply


governments, global regulators, customers and supply chain partners to make sure that their products are


chain partners to make sure that their products are sustainable. Optimising drug delivery systems so that


they comply with sustainability regulations without compromising patient safety is, however, a challenge


have not traditionally regarded sustainability as part of their remit.


of their remit. Regulations covering sustainability vary from


Regulations covering sustainability vary from


jurisdiction to jurisdiction. The EU’jurisdiction to jurisdiction. The EU’s 2019 Green Deals 2019 Green Deal, a, a package of measures and directives designed to reduce


package of measures and directives designed to reduce 10


sustainable. Optimising drug delivery systems so that they comply with sustainability regulations without


compromising patient safety is, however, a challenge both for pharma companies and regulatory bodies such


both for pharma companies and regulatory bodies such as the US Food and Drug Administration (FDA) that


as the US Food and Drug Administration (FDA) that have not traditionally regarded sustainability as part


and production process must meet stringent standards, which can vary from country to countryiwh ch can vary from country to country.


use of recycled and recyclable packaging, as well as the removal of micropollutants and the restriction of


the removal of micropollutants and the restriction of environmentally harmful chemicals.


environmentally harmful chemicals. The US too has a number of environmental


The US too has a number of environmental regulations that apply to pharma, enforced by agencies


regulations that apply to pharma, enforced by agencies such as the Environmental Protection Agency (EPA)


such as the Environmental Protection Agency (EPA) under laws like the Clean Air Act and Clean Water Act,


under laws like the Clean Air Act and Clean Water Act, which require companies to manage emissions and


which require companies to manage emissions and waste. While Good Manufacturing Practice (GMP)


waste. While Good Manufacturing Practice (GMP) focuses on product quality and safety, it does not


management in line with International Council for Harmonisation of Technical Requirements for


focuses on product quality and safety, it does not directly govern environmental emissions and waste


directly govern environmental emissions and waste management in line with International Council for


Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Pressure also comes from customers, says Michaela Fuetsch, head of PT chemical and environmental


Pharmaceuticals for Human Use (ICH) guidelines. Pressure also comes from customers, says Michaela Fuetsch, head of PT chemical and environmental


www.worldpharmaceuticals.net


carbon emissions, has been particularly influential in the drive to improve sustainability, underpinning and


the drive to improve sustainability, underpinning and driving related legislation that includes targets for the


driving related legislation that includes targets for the use of recycled and recyclable packaging, as well as


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