Research landscape analysis for quality in Pharma 4.0 era

Reza Vatankhah Barenji, Reza Ebrahimi Hariry, Denizhan Demirkol and Tugrul U. Daim

Technology in Society, 2024, vol. 76, issue C

Abstract: 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.

Keywords: Pharmaceutical quality; Quality by design; Process analytical technology; Real-time release testing; Industry 4.0; Pharma 4.0 (search for similar items in EconPapers)
Date: 2024
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Citations: View citations in EconPapers (1)

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Persistent link: https://EconPapers.repec.org/RePEc:eee:teinso:v:76:y:2024:i:c:s0160791x24000204

DOI: 10.1016/j.techsoc.2024.102472

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