Pharmaceutical products directly impact consumer health and well-being. Owing to which, these products are subject to stringent regulations. Pharmaceutical manufacturers must comply with safety and quality standards to bring their products to the market. With the rapid expansion of the pharma sector, small and mid-sized pharmaceutical players are focused on complying with regulations and investing in research and development to deliver better products to customers and stay competitive in the market.
Most companies operating in developing countries such as India and China export their products to the U.S. These products are regulated by the U.S. Food and Drug Administration (FDA). To ensure the safety of pharmaceutical products sold in the U.S., the FDA inspects the facilities and procedures of all pharmaceutical manufacturers (in the U.S. and those overseas) that regularly sell their products in the U.S. Hence, these companies must be registered with the FDA and adhere to the FDA's current good manufacturing practices (cGMP). Additionally, manufacturers must follow ICH Guideline Q10, 21 CFR Part 211, and International Organization for Standardization (ISO) guidelines to produce and market their products. With the increasing importance of regulatory requirements and growing international markets, pharmaceutical manufacturers are keen on adopting quality management systems.
Pharmaceutical quality management systems help pharmaceutical organizations coordinate and direct their activities to meet regulatory and customer requirements. The constant pressure on pharmaceutical companies to increase production capacities while adhering to regulatory guidelines has increased the need for pharmaceutical quality management systems.
Biopharmaceuticals are adopted faster than conventional synthetic drugs due to their ability to target specific molecules, lower side effects, and high activity and specificity. Biopharmaceuticals are increasingly being used for treating immune-mediated inflammatory diseases (IMIDs), including rheumatic diseases, such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and cancer. Quality management systems are essential in the biopharmaceuticals sector to ensure standardized and high-quality products. Biopharmaceutical firms can ensure constant adherence to quality standards, compliance with regulations, and continual improvements in organizational processes by deploying QMS. Quality management systems allow pharmaceutical & biopharmaceutical companies to increase overall customer satisfaction, reduce the risk of product recalls, and improve product quality.
Integrating artificial intelligence (AI) and machine learning in the pharmaceutical QMS is further expected to drive market growth. The integration of AI into quality management systems offers several benefits, one of which is the capacity to analyze enormous volumes of data accurately and quickly. Manually recognizing data patterns and trends is difficult; however, AI-powered systems can run analyses effectively and efficiently, enabling better decision-making, quicker problem-solving, and ultimately, better quality control.
Artificial intelligence can also be used to update QMS automatically in reaction to changes in legislation to ensure compliance. Artificial intelligence may be used to identify possible compliance concerns at an early stage, in addition to analyzing data from quality management systems. Looking at the benefits of AI and machine learning integration in QMS, market players are focused on the launch of integrated QMS for the life science industry. For instance, in April 2023, Dot Compliance (U.S.) introduced an AI-based electronic quality management system for the life sciences sector. The system includes proprietary algorithms and ChatGPT to enhance pharmaceutical organizations’ compliance.
Pharmaceutical companies growing need to comply with regulatory requirements, the rapid growth of the pharmaceutical industry and the benefits of software-based quality management systems are driving the adoption of pharmaceutical quality management systems. According to Meticulous Research®, the global pharmaceutical quality management systems market is expected to register a CAGR of 15.6% to reach $3.97 billion by 2030.
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