Purpose <p>This study explores emerging digital innovations in pharmaceutical manufacturing, as well as the opportunities and challenges they present for product quality and batch release. A secondary objective was to discuss the regulatory compliance of these digital innovations.</p> Method <p>A comprehensive systematised literature review was performed using Web of Science, PubMed, and Scopus research databases. Screening of the identified studies was performed using Covidence online software. The Mixed Methods Appraisal Tool (MMAT) was adapted for the risk of bias assessment.</p> Results <p>38 studies were included after screening and risk of bias assessment. The thematic analysis identified 5 empirical themes: ‘PAT and RTRT’ ‘AI’, ‘Process Modelling’ ‘IoT’, and ‘Data Management’. The main opportunities identified included prediction of product quality and variability, deviation root cause analysis, real-time process monitoring, and adaptive control to prevent out of specification products. This study didn’t identify any regulatory challenges to these technologies, however challenges included a lack of personnel with the required technical expertise, data security risks, validation challenges, and potential for inaccuracy.</p> Conclusions <p>Emerging digital technologies are being used to support pharmaceutical quality. A review of current guidance did not uncover any regulatory obstacles to theimplementation of the identified technologies, once part of the registered manufacturing process. More opportunities than challenges were identified in the literature. Based on this study, we propose a responsible strategy for future digital innovation implementation and conclude that there is value in (1) Adopting digital innovations in pharmaceutical manufacturing and (2) Supporting digital education for QPs and other quality professionals in pharmaceutical manufacturing.</p>