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An outlook on regulatory aspects of 3D printing in pharmaceutical and medical sectors

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Review Article

Author Details : Lakshmi Prasanthi Nori*, S.S. Manikiran

Volume : 4, Issue : 3, Year : 2022

Article Page : 98-108

https://doi.org/10.18231/j.ctppc.2022.017

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Abstract

Background: Since the time of origin, three-dimensional printing has not only mesmerizing the researchers also health professionals too. Even though the process is exciting, it involves fussy coordination and selection process to get a desirable product. Still the manufactures are in confusion state that to follow which regulations and guidelines to gets an approval for their product of 3d printing.
Materials and Methods: The importance of 3D printing has laid to recognize the best suitable product and ways to prevent its misuse. FDA approved more than 100 3D printed medical devices and it includes Orthopedic, Cranial implants, Dental restorations such as crowns and external prosthetics, surgical instruments. It also approved one 3D printed drug product using Zip Dose technique for the treatment of Epilepsy called SPRITAM (levetiracetam).
Conclusion: The objective of this review article is to give a brief introduction, history, evolution of 3D printers, their development process, FDA role and guidelines.

Keywords: 3D printing, FDA, ASTM standards, ZipDose technique, Medical devices

How to cite : Nori L P, Manikiran S, An outlook on regulatory aspects of 3D printing in pharmaceutical and medical sectors. Curr Trends Pharm Pharm Chem 2022;4(3):98-108

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