Volume-1 ,Issue-2, September-2025

Global Journal of Pharmaceutical and Scientific Research (GJPSR)

Abstract

A REVIEW SOFTWARE COULD DRIVEN ARCHITECTURE IN MODERN PHARMA 4.0

Mohd. Wasiullah[1], Dr. Piyush Yadav[2], Vivek Yadav[3], Dr. Shashikant Maurya[4]*
1. Principal, Department of Pharmacy, Prasad Institute of Technology, Jaunpur, U.P., India 2. Head: Department of Pharma: Chemistry, Prasad Institute of Technology Jaunpur, U.P., India 3. Scholar- Department of Pharmacy, Prasad Institute of Technology, Jaunpur, U.P., India 4. Principle - Department of Pharmacy, Prasad Polytechnic Jaunpur, U.P, India.

Abstract

The pharmaceutical industry is undergoing a major digital transformation driven by Pharma 4.0, in which software-driven architectures enable intelligent, integrated, and data-centric operations. This review examines the role of software-driven architecture through the integration of core enterprise and manufacturing systems with advanced digital technologies. Key platforms—including Manufacturing Execution Systems, Enterprise Resource Planning, Laboratory Information Management Systems, Quality Management Systems, and Product Lifecycle Management—are highlighted as the digital backbone supporting end-to-end visibility, regulatory compliance, and lifecycle-based quality management. The impact of emerging technologies such as artificial intelligence, big data analytics, the Internet of Things, digital twins, and blockchain on drug development, smart manufacturing, continuous production, and supply chain optimization is discussed. In addition, challenges related to data integrity, system validation, cybersecurity, and organizational readiness are addressed, alongside future trends such as autonomous manufacturing, personalized medicine, and the evolution toward human-centric Pharma 5.0. Overall, this review underscores the strategic importance of software-driven Pharma 4.0 for achieving operational excellence and sustainable innovation in the pharmaceutical industry.
Keyword: Pharma 4.0; Software-driven architecture; Digital transformation; Pharmaceutical manufacturing; Manufacturing Execution Systems (MES)