Abstract
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.
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Notes
- 1.
The Quality by Design and Quality Risk Management guidelines, specifically manual ICH Q8 and Q9, are being broadly internalized by the sanitary agencies in several countries.
ICH Q8—Implementation status: EC, Europe—Implemented (1 June 2009); Reference: CHMP/ICH/167068/2004; FDA, United States—Implemented (1 November 2009); Reference: Vol. 71, No. 98; HSA, Singapore—Implemented (1 January 2013); Reference: ASEAN Guidance for Quality By Design as an Alternative Approach to Process Validation; Health Canada, Canada—Implemented (11 February 2016); Reference: File #: 16-101390-659; MFDS, Republic of Korea—Implemented (1 December 2008); Reference: Guideline of Pharmaceutical Development [Guideline-0211-01] Quality Review Guidance for the Introduction of Quality by Design [Guideline-0214-01]; MHLW/PMDA, Japan—Implemented (1 June 2010); Reference: PFSB/ELD Notification No. 0628-1; Swissmedic, Switzerland—Implemented (1 August 2009); Reference: ICH website; In process: Brazil and China.
ICH Q9—Implementation status: FDA, United States—Implemented (1 June 2006); Reference: Vol. 71, No. 106, p. 32105-6; HSA, Singapore—Implemented (1 January 2013); Reference: ASEAN Guidance for Quality By Design as an Alternative Approach to Process Validation; Health Canada, Canada—Implemented (5 February 2016); Reference: File #: 16-100155-230; MFDS, Republic of Korea—Implemented (1 December 2008); Reference: Guideline of Quality Risk Management [Guideline-0214-01]; MHLW/PMDA, Japan—Implemented (1 September 2006); Reference: PFSB/ELD Notification No. 0901004; NMPA, China; Reference: NMPA Released Announcement on the Recommended Application of 4 ICH Guidelines Including Q8(R2): Pharmaceutical Development (No. 6, 2020). Swissmedic, Switzerland—Implemented (9 November 2005); Reference: ICH website. In the process of implementation: ANVISA, Brazil and NMPA, China (ICH 2020).
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Dias, A.L., Ferreira, N.N., Ferreira, L.M.B., Pedreiro, L.N., dos Santos, A.M., Gremião, M.P.D. (2021). Regulation of Nanotechnology-Based Products Subject to Health Regulations: Application of Quality by Design (QbD) and Quality Risk Management (QRM). In: Eloy, J.O., Abriata, J.P., Marchetti, J.M. (eds) Nanocarriers for Drug Delivery. Nanomedicine and Nanotoxicology. Springer, Cham. https://doi.org/10.1007/978-3-030-63389-9_13
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