Concept paper and roadmap for "Compliant by Design" strategies released

A newly released public deliverable of the ETERNAL project lays out the key-drivers and a possible regulatory roadmap for “compliant-by-design” strategies applying the concepts of “greener design” to be delivered in Europe.

The report, authored by international Scientific, Safety and Regulatory Affairs consultancy company Asphalion, argues that whilst there is not currently a specific framework for green drivers in the pharmaceutical industry, by using current principles and ideas of pharmaceutical development and updating them to a "greener" perspective (gQTPP, and gControl Strategy), a line of argument can be applied from the start of a project to construct a control strategy to achieve a "greener" development of pharmaceutical products.

The report first presents an overview of current legislation within EU framework for human medicines that has a direct impact in the initial development of any pharmaceutical product, and other legislation that impacts on direct inputs or requirements of concern during the development, clinical trials, marketing authorization and post-commercialization phase, including those that are being revised or under consultation. Secondly it highlights (in the context of the European Commission’s current undertaking to comprehensively revise EU general legislation pertaining to human medicinal products) three key “inputs”: the pharmaceutical supply chain, Environmental Risk Assessment, and the vital nature of medicines for human health.

The authors illustrate the applicability of the new approach to an industrial case study within ETERNAL in which a generalized method for continuous drug product manufacturing process is being developed in order to reduce environmental impact (energy and materials) of the drug product formulation process, reduce operating costs, and potentially improve product quality, consistency and time to market.

With the new proposal of gQTPP, the principles of pharmaceutical development based on QTPP and CQAs can be leveraged to enable, control and ensure sustainable developments with less impact on the environment.

Download report

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