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Regulatory Perspectives on 3D Printing in Pharmaceuticals

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3D Printing of Pharmaceuticals

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 31))

Abstract

The genomic revolution and the age of personalized medicine has exponentially increased in interest and understanding since its introduction in the last decade. Embracing innovation, the United States Food and Drug Administration (FDA) approved the first three-dimensional (3D) printed drug product and thus, has set the benchmark for an industrial revolution in pharmaceutical manufacture. Regulatory standards, however, require each product of each batch to be within specifications with respect to purity, impurities and quality. The regulatory environment of individual countries, however, differ in terms of manufacturing, distribution and compounding of drug products and thus, need to be fundamentally considered for on-demand and industrial pharmaceutical 3D printing. In the past, it would have seemed like science fiction to design and produce our medicines with 3D printing technology, but it is now certainly becoming reality that will only grow further. This chapter aims to discuss the current regulatory environment for 3D printing mass production and the regulatory gaps and challenges that need to be acknowledged to advance the modern manufacture of medicines.

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Notes

  1. 1.

    Center for Drug Evaluation and Research

  2. 2.

    Center for Devices and Radiological Health

  3. 3.

    Center for Biologics Evaluation and Research

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Author information

Authors and Affiliations

  1. Office of Pharmaceutical Quality, The US FDA, Silver Spring, MD, USA

    Akm Khairuzzaman

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  1. Akm Khairuzzaman
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Correspondence to Akm Khairuzzaman .

Editor information

Editors and Affiliations

  1. Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

    Abdul W. Basit

  2. Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

    Simon Gaisford

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Khairuzzaman, A. (2018). Regulatory Perspectives on 3D Printing in Pharmaceuticals. In: Basit, A., Gaisford, S. (eds) 3D Printing of Pharmaceuticals. AAPS Advances in the Pharmaceutical Sciences Series, vol 31. Springer, Cham. https://doi.org/10.1007/978-3-319-90755-0_11

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