What type of study is this?

This is a Systematic Review study.

What question did this study set out to answer?

The review aims to synthesize existing validation frameworks for three-dimensional printed personalized medicines and address quality assurance challenges.

April 29, 2026Open Access

Quality Assurance in Decentralized Manufacturing: A Review of Validation Frameworks for 3D-Printed Personalized Medicines

Key Points

The review aims to synthesize existing validation frameworks for three-dimensional printed personalized medicines and address quality assurance challenges.
Review of Scopus-indexed literature from 2019 to 2026 following PRISMA guidelines.
Focus on point-of-care manufacturing, real-time release testing, and data integrity.
Assessment of technical modalities including Fused Deposition Modeling, Semi-Solid Extrusion, and Selective Laser Sintering.
Identification of the Hub-and-Spoke model as a feasible decentralized quality assurance structure.
Near-Infrared and Raman spectroscopy enabled real-time verification of doses with high accuracy (R2 = 0.98).
Digital Twin technology enhances process validation and predictive maintenance.

Abstract

Background The pharmaceutical industry is in a paradigm shift in which the mass-production model based on one-size-fits-all is being replaced by the patient-centric model that is made possible by three-dimensional printing (3DP) and decentralized manufacturing (DM). Although 3DP enables the personalization of dosage form as never before, the translation of the technology into clinical practice is complicated by the complicated quality assurance (QA) and validation barriers. Purpose: This review critically synthesizes the existing validation frameworks of 3DP personalized medicines with special emphasis on the combination of Process Analytical Technology (PAT), Digital Twins, and the recently implemented UK MHRA 2025 regulatory framework. Methodology: Scopus-indexed literature (20192026) was searched in a PRISMA-compliant systematic search that focused on point-of-care (POC) manufacturing, real-time release testing (RTRT), and data integrity. Core Mechanisms: We consider technical modalities, such as Fused Deposition Modeling (FDM), Semi-Solid Extrusion (SSE), and Selective Laser Sintering (SLS), their respective Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Findings: The review identifies the Hub-and-Spoke model as the most feasible structure of decentralized QA with centralized hubs that address the issue of integrity of the pharma-ink and decentralized spokes that address the issue of process validation. In-line Near-Infrared (NIR) and Raman spectroscopy technologies that enable the real time release of doses are accurate and non-destructive (R 2 = 0.98) and allow real time verification of doses. Moreover, the Digital Twin technology improves three-stage process validation lifecycle, providing predictive maintenance and proactive quality management. Conclusion: To attain sustainable clinical implementation of the 3DP, a radical change toward Quality-by-Design (QbD) and a powerful digital infrastructure is required. In the coming 2026 and beyond, we suggest a roadmap to standardize decentralized validation to achieve the best safety and efficacy of personalized medicines.

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