With increasing complexities across the pharmaceutical industry and a rise in novel drug development, drug manufacturing has become one of the most strictly regulated sectors in the past few years. Also, as the emphasis on the declining side effects of various drugs and improving drug effectiveness continues to grow, the importance of enhancing quality is becoming crucial in the life science industries.
Pharmaceutical quality professionals face more obstacles and have more opportunities than ever before to improve the quality and compliance of drugs and bionics. Increasing complexity in supply chains
, tightening regulations, and growing data integrity issues are compelling pharmaceutical companies to adopt quality processes and quality management solutions on a day-to-day basis. In addition, regulatory bodies such as the Food and Drug Administration (FDA) and others are increasingly focusing not only on compliance but also on developing a culture of quality management in the pharmaceutical sector.
Why are Pharmaceutical Quality Management Systems Gaining Importance?
Presently, inspectional FDA 483s, import alerts, warning letters, and notices of violations from regulatory authorities are emerging as the biggest obstacles for pharmaceutical manufacturers. The role of quality management systems is of great significance in the pharmaceutical drug manufacturing
Understanding and implementing an effective quality management system model enables a pharmaceutical organization to meet its regulatory and ethical obligations, which include the management of the quality, efficacy, safety, identity, and purity of finished medicinal products.
Every pharmaceutical industry must adhere to a variety of rules and specifications established by a number of international regulations. A quality management system is used to maintain the quality of pharmaceutical products. It assists in organizing and managing all records, processes, and workflows, ultimately improving overall product quality. When supported by any IT system or paper-based methodology, it also aids the organization in meeting current and future regulatory standards.
Here are some reasons why quality management systems are so important for pharmaceutical companies
Enhancing Manufacturing Efficiency
Improving Product Assessment
Decreasing Human Errors
Compliance with Industry Best Standards
Optimize Processes, Products, and Systems
Data from a quality management system can also be set up in a way that allows for consistent risk calculations, metrics, FDA and ISO compliance, and other trend analysis.
The Way Forward
A quality management system is the core of any quality and assurance
(Q&A) and compliance process. It is a regulatory requirement that the Central Drugs Standard Control Organization and other global regulatory bodies consider critical.
With drug approvals getting stricter and new automated manufacturing processes being used, leading pharmaceutical companies are adopting these solutions to cut down on audit time and findings and reduce the risk of product recalls.
Driven by this, the sales of pharmaceutical quality management solutions are estimated to top $2.9 billion by 2026 end. Developers and providers of quality management solutions are likely to invest more in development of pharmaceutical-specific software to capitalize on this opportunity.