The Role of Digital Transformation in Pharmaceutical Manufacturing Technology Optimisation With a Focus on Critical Process Parameters (CPP) In India

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Authors
Thankachan, Ashly
Issue Date
2024
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In this study, the current state of digital transformation in pharmaceutical manufacturing was investigated, focusing on the adoption of advanced digital tools for Critical Process Parameter (CPP) monitoring and control. A qualitative approach using semi-structured interviews with key stakeholders from various pharmaceutical manufacturing organizations, including formulation scientists, regulatory professionals, and digital technology specialists, was employed to gain comprehensive insights into the implementation and impact of these technologies. Results revealed widespread adoption of digital tools such as Process Analytical Technology (PAT), Artificial Intelligence (AI), Machine Learning (ML), and Internet of Things (IoT) in pharmaceutical manufacturing. These technologies have significantly enhanced real-time monitoring and control of CPPs, improved process efficiency, and strengthened adherence to Quality by Design (QbD) principles. The integration of these advanced technologies has shown promising improvements in product quality and regulatory compliance. However, the study also identified significant barriers to adoption, including technological challenges, organizational resistance, and regulatory hurdles. These findings highlight the complex landscape of digital transformation in the pharmaceutical industry, where innovation must be balanced with practical implementation challenges and stringent regulatory requirements. The study emphasizes the need for a strategic approach to digital transformation in pharmaceutical manufacturing. It underscores the importance of addressing technological, organizational, and regulatory barriers to fully realize the benefits of advanced digital tools. These insights provide valuable guidance for pharmaceutical companies, technology providers, and regulators in optimizing the integration of digital technologies to enhance manufacturing processes, ensure product quality, and maintain regulatory compliance in this highly regulated industry.

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