| |JANUARY 202419Automation: Automated validated production processes make it easier for pharmaceutical manufacturers to ensure compliance with all relevant regulations and help in improving the efficiency of pharmaceutical development and production by streamlining the processes. Technological advances and robotics are enabling the pharmaceutical industry to increase the speed and accuracy of their processes such as filling, packaging, and inspection.Integrated Manufacturing Lines: The major concern under current good manufacturing practices is to fully contain the product during processing, thereby protecting both operators and the environment. Integrated process systems not only offer containment, but also provide improved productivity through automation, increased yield, and efficient cleaning procedures.Continuous Manufacturing Lines: The pharmaceutical industry is looking at continuous processing to improve production quality in an efficient and cost-effective way and to comply with the increasingly stringent manufacturing acceptance criteria put in place by the regulatory authorities.Benefits of Automation include maximal end-product safety using online quality control with faster testing, saving on labor, and energy savings of 0.5­5 percent yield improvement.Advanced Software: Software modules are already available that can help to simulate new drug candidates which can be eventually introduced as potential drug molecules to be considered for future development.Artificial Intelligence in Manufacturing: AI combined with Machine Learning (ML) is also assisting pharmaceutical companies to ensure quality throughout the process. The pharmaceutical industry utilizes data-driven solutions in both Research & Development (R&D) and routine manufacturing phases.FDA currently supports the application of an improved development approach, e.g., quality by design (QbD) in the R&D phase, and it also supports the use of process analytical technology (PAT) as a tool to support continuous manufacturing.Artificial Intelligence in Research and Development: Physiologically based pharmacokinetic (PBPK) determines chemical exposure to the amount of chemicals found in the blood and organs at different times. Physiologically based biopharmaceutics modeling (PBBM) correlates physicochemical properties with physiological parameters to determine the absorption and pharmacokinetics of drugs. Dissolution simulation software simulates intravenous, oral, oral cavity, ocular, inhalation, dermal, subcutaneous, and intramuscular absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals.What are the major challenges faced by pharma companies in adapting to new technologies?With the government of India allowing 100% Foreign Direct Investment (FDI) in the pharmaceutical sector for greenfield pharmaceuticals, brownfield pharmaceuticals, and 74 percent under the automatic route, initial investment remains a major challenge for many players to adopt new technologies.Other challenges include Infrastructure development and operational costs, collaboration with experts.The application of QbD will ensure a consistent and robust product. Through the use of PBPK and PBBM models, formulations can be optimized to generate optimum in vitro-in vivo correlation
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