Three-Dimensional Printing in Pharmaceutical Manufacturing: Ensuring Data Integrity through ALCOA+ Principles and Regulatory Compliance

Abstract

Three-dimensional printing (3DP) or additive manufacturing is transforming pharmaceutical sciences by on-demand production of customized drug products. The technology provides patient-specific dosing, intricate geometries, and multiple drug combinations simultaneously, presenting solutions to special therapeutic needs populations. This review assesses the existing 3DP technologies relevant in pharmaceutical production and detects the data integrity, quality control, and regulatory compliance challenges. Most important to successful integration of 3DP in medicine is compliance with ALCOA+ principles to guarantee accuracy, traceability, and security of manufacturing and digital data. High-risk concerns like file tampering, firmware hacking, and version discrepancies are addressed along with solutions such as block chain, electronic batch records, and process monitoring systems. Risk assessment tools and regulatory guidelines (e.g., 21 CFR Part 11, EudraLex Annex 11) are addressed. The article summarizes that although 3DP facilitates never-before-seen tailoring as well as decentralization, its safe use in pharmacy application requires strong data management, guaranteed documentation systems, and quality controls integrated from design to finished product.