Regulation of Nanotechnology-Based Products Subject to Health Regulations: Application of Quality by Design (QbD) and Quality Risk Management (QRM)

Nanotechnology and nanomaterials have rapidly evolved and are used in a wide range of areas. When dealing with products that are subject to health regulations, nanotechnology-based products face a great challenge. Although nanotechnology-based products are already commercially available, there are currently no unified international guidelines, and most respected regulatory agencies consider different aspects. Furthermore, a few important gaps in knowledge still need to be filled so that safety and efficiency can be guaranteed in all nanotechnology-based products that require sanitary regulation. However, even after efficiency and safety are well-defined, significant challenges associated with the conception and operation of production processes can be directly linked to the final quality of these products. In face of the diversity and complexity of these products, a regulatory evaluation must be based on profound scientific knowledge and must assess potential risks. In this scenario, the Quality by Design (QbD) and Quality Risk Management (QRM) methods can synergistically contribute to elaborating guidelines that are in compliance with regulatory demands. The first method, QbD, is a systemic approach to product development and is based on predefined objectives. The second, QRM, is a systematic process for evaluating, controlling, and inspecting product quality throughout its pharmaceutical life cycle. Applying the elements of QbD and QRM systemizes acquisition of knowledge by scientific approach and uses elements of risks and opportunities throughout the process, which is especially important when developing products based on nanotechnology which are subject to sanitary regulation. In this chapter, we will discuss the international regulatory guidelines adopted for nanotechnology-based products that require sanitary regulation. We will also analyze QbD and QRM methodologies, which can be adopted when developing such products. In order to contextualize the theoretical discussion, this chapter will also present examples of how these guidelines have been applied. Case studies of commercially available nanotechnology-based products subject to the regulatory health approach will be also be presented and analyzed.