Investigating the Current Challenges Involved in the Application of Process Analytical Technology (PAT) Methodologies in Pharmaceutical Industry

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Kumar Dugginapalli, Santosh
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The application of Process Analytical Technology (PAT) methodologies in the pharmaceutical industry has gained significant attention due to its capability to enhance process control, improve product quality, and increase manufacturing efficiency. However, several challenges delay the widespread adoption and implementation of PAT in this industry. There are technological challenges, including the need for reliable and robust analytical instrumentation, suitable for real-time monitoring of critical process parameters and quality attributes. Additionally, the complexity and variability of pharmaceutical processes create challenges in developing efficient multivariate models for process control and optimization. Despite extensive research and investments involved in the implementation of PAT, the underlying challenges are yet fundamental and highly overlooked. These gaps prompted to understand the challenges involves in PAT implementation by conducting an extensive secondary research study with the current literature available. Once the possible gaps have been identified a draft from the current literature is made to plot the objectives and goals of the study. The study in this thesis seeks to analyse the challenges involved in the implementation of PAT technology in the pharmaceutical industry. For the primary research study, five members with industry experience not less than 2 years and suitable exposure to PAT implementations have been approached. The members were then initiated to participate in consent driven semi-structured interviews remotely using google meet. Gioia method of data analysis was used in the study to study and analyse the qualitative data obtained from the semi-structured interviews. The study results reveal that the challenges related to Product, Personnel and Funding are the primary challenges and Technical, Process Planning and Intellectual Property challenges were secondary cause for delay in adoption and deter the implementation of PAT technology across the industry. The challenges identified in the study are not only limiting the progress of PAT implementation but also affecting the industry by increased manufacturing costs and undue process quality tests. Through this study pharmaceutical industry to achieve success collectively PAT implementations must be considered as a vital innovative step towards Pharma 4.0 than a process enhancer. The present research study contribution will be beneficial for academic researchers, regulators, pharmaceutical companies, and consumers.

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