Research landscape analysis for quality in Pharma 4.0 era

• Published in: Technology in society 2024-03, Vol.76, p.102472, Article 102472
• Main Authors: Barenji, Reza Vatankhah, Hariry, Reza Ebrahimi, Demirkol, Denizhan, Daim, Tugrul U.
• Format: Article
• Language: English
• Subjects: Industry 4.0; Pharma 4.0; Pharmaceutical quality; Process analytical technology; Quality by design; Real-time release testing
• ISSN: 0160-791X; 1879-3274
• DOI: 10.1016/j.techsoc.2024.102472

This study focuses on the production phase of drug development and examines approaches and their progress indicators for enhancing the quality of pharmaceutical products and attaining consistency in Pharma 4.0. The research is conducted in three interconnected stages. In the first stage, a scientometric approach is incorporated into a detailed analysis of past studies, utilizing bibliometric analysis techniques. Following this, a narrative literature review is conducted based on the outcomes of the first stage to gain deeper insights into the selected technologies. Approaches for effective quality improvement include incorporating Quality by Design (QbD) for product and process development, utilizing Process Analytical Technology (PAT) in pharmaceutical processes, and adapting Real-Time Release Testing (RTRT) for quality control of raw materials, semi-products, and final products. While each of these approaches should be effectively implemented, integration with others is also necessary to maintain consistent quality. In the final stage of this paper, the authors make the first attempt to present a future-oriented integrated quality consistency system under the Pharma 4.0 philosophy, which encompasses effective production for quality improvement and consistency. •Bibliometric extraction of the technologies for quality improvement in drug products.•Technologies ensuring consistency in drug products.•A future-oriented integrated quality consistency system.