Development of Automated Quality Assurance Systems for Pharmaceutical Manufacturing: A Review
Main Article Content
Abstract
Automation has revolutionized the pharmaceutical manufacturing industry, with various applications such as High-Quality Risk management, Quality by Design (QbD), Process Analytical Technology (PAT), Anti-counterfeit technologies and so much more. In this abstract, we highlight real-time industry examples of automation in pharmaceutical manufacturing, including in-situ analysis in integrated continuous manufacturing systems with PAT, data-rich experiments using automated lab reactors and in-situ sampling, and tamper-evident packaging solutions utilizing deep learning and machine vision foil inspection. The potential for personalized medicines and drug discovery has also been enhanced through automation, allowing for faster and more precise analysis of data, resulting in the development of tailored treatments for individual patients. Automated filling, packing, and labeling processes have improved accuracy and reduced the risk of counterfeit products in the market. Automated continuous manufacturing has enabled real-time monitoring and control of the manufacturing process, leading to higher product quality and reduced production time.The utilization of data-rich experiments and in-situ sampling in automated lab reactors has sped up faster data analysis, leading to improved process optimization and reduced development time for new drug formulations. The implementation of automation has also transformed the roles and responsibilities of quality assurance systems in the pharmaceutical industry. These now comprise digital data handling and interpretation, automated data collection, , electronic batch records, and ensuring confidentiality and data integrity. In conclusion, automation has transformed the pharmaceutical manufacturing industry by enabling high-quality risk management, process analytical technology, personalized medicines, and anti-counterfeit technologies. Automation has also enhanced drug discovery, filling, packing, labeling, and continuous manufacturing processes, leading to improved product quality, efficiency, and patient safety in the pharmaceutical industry. The roles and responsibilities of quality assurance systems have evolved to include digital data handling, automated data collection, and maintaining data integrity.
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