Quality management is an integral philosophy for consistently improving the quality of manufactured pharmaceutical products. The initial framework for total quality assurance in industrial organizations requires an assortment of regulated inspections, streamlined procedures, and standardized conditions. As quality standards continue to rise in the industry—and on a global scale—the necessity for continuous improvement also arises.
Quality management for regulated industries involves a Quality Management System that enhances product safety and ensures FDA compliance. How can pharmaceutical companies use resources wisely to pave the way for quality assurance? Let’s examine the leading ways to improve quality in pharmaceutical manufacturing and retrofit quality management systems.
Industry 4.0: Instrumentation and Automation
Quality management systems within the pharmaceutical industry require analytical, critical thinking. Out of all the major ways to improve quality in pharmaceutical manufacturing, automated systems top the list. Automation tools and technologies are steadily emerging to enhance manufacturing technologies and compliance in this incredibly complex industry. Smart technology, integrated IT systems, and the Internet of Things work together to meet quality specifications in the supply chain. Automotive processes open doors to reduce the risk of contamination and human error, maximizing the potential for consistent, higher-quality products.
Less Room for Error: Leveraging Monitoring Technology
Falling prey to theoretical thinking is a possibility within the pharmaceutical industry. Instead, designing efficient and effective quality-producing processes warrants an engineering-based strategy. Developing solutions for quality control requires leveraging current technologies and evidence-based decision-making. Collected data reveals systemic issues, identifies problematic bottlenecks, and predicts future performance. Reaping the full benefits of data-driven assets is attainable through proactive monitoring and tracking software and structured systems.
Streamlined Operations: A Process-Centered Approach
A process-centered approach is the core principle for predictable and consistent results. Manufacturers can produce high-quality products with streamlined processes at each operational step of production. This approach requires a greater focus on the entire product’s life cycle from initial strategy, raw materials, testing, site application, and end-to-end solutions. Data-driven techniques can measure product quality and consistency to provide a comprehensive, augmented picture.
Moravek is a GMP certified manufacturer for leading Biopharma companies and institutions for pharmaceutical research and development. We’re a state-of-the-art manufacturing organization for GMP APIs that meet the standards of regulatory agencies, such as the FDA and the ISO, and we also have over 40 years of experience. Moravek also uses fully compliant management and monitoring systems, such as ECM and EMS, in our quality control approach. Reach out to us to learn more about our facility, Quality System, and operating procedures to tailor your campaign or project today.