Three-dimensional (3D) printing is an exponentially growing technology in pharmaceuticals. It is layer-by-layer deposition of polymer on a solid substrate, offering various opportunities for the development of personalized medicines, patient-specific dosing and safe solid dosage forms. This technology has been applied in several pharmaceutical and biomedical products like microchips, modified drug delivery, fast disintegrating tablets, and implants. Furthermore, the USFDA’s approval to Spritam®(levetiracetam), a 3D printed tablet and a few medical devices approved by different regulatory agencies demonstrated great market potential. However, besides many benefits, 3D printing technology presents a number of regulatory challenges. These products cannot be tested using traditional quality-by-testing (QbT) methods, which are time-consuming, laborious, and destroying. Therefore, considering the limitations, the current chapter explores the application of quality-by-design (QbD) approach and process analytical technology (PAT) tool for the fabrication and testing of 3D printed medicines and devices. Effective QC strategies relating to material selection, process validation and consistency of the 3D printed medications are discussed. The chapter delves into the framework and process required for 3D printed product approval by various national medical regulatory agencies. Overall, it illustrates and delivers insights regarding the utilization of the 3D printed products considering the product quality, safety and efficacy.