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By Jahnavi Kharidia

Jahnavi Kharidia-finalToday, the pharmaceutical industry’s antiquated drug development model is facing many challenges from the public and international regulatory agencies. The ongoing trends of increasing cost and inefficiency have raised serious concerns. Regulatory agencies are struggling with persistently increasing complexity of manufacturing processes for pharmaceutical products and their concomitant loss of quality. Efficiency in the development of new pharmaceutical products can be improved by establishing sound and appropriate processes. Integration of good manufacturing practices and good science is necessary to improve the productivity of the pharmaceutical industry.

Quality by design (QbD) is a scientific, risk-based, logistic, and proactive approach that is designed to streamline the pharmaceutical drug development process by intentionally incorporating principles of quality control directly into every step of the manufacturing process. The key elements of QbD include knowledge of variability in raw materials, critical process parameters of the manufacturing process, and critical quality attributes of the drug product.

The principles of QbD allow us to gain understanding around how manufacturing processes and formulation parameters affect product performance. Understanding and identifying critical process parameters is essential in order to monitor these parameters in real time in the production process thereby allowing improvements in manufacturing processes. Regulatory agencies strongly encourage the pharmaceutical industry to adopt such QbD approaches to make a quality product; however, there are industrial and regulatory challenges in implementing such paradigms.

The pharmaceutical industry is currently struggling to gain knowledge and experience with QbD principles while the regulatory agencies are facing challenges associated with implementing these new QbD concepts into practice. Industry will have to work closely with the regulatory agencies to overcome the regulatory challenges associated with implementing QbD and strive to deliver quality products in a more cost-effective and time-efficient manner.

QbD and Regulatory Challenges will be an important theme at the 2015 AAPS Annual Meeting and Exposition. This theme will provide attendees with the opportunity to learn more about QbD and its implementation in manufacturing a quality product that begins with predefined objectives and is based on utilizing sound science and incorporating quality risk management strategies.

Jahnavi Kharidia, Ph.D., FCP, RAC, is director of the Clinical Pharmacology Group at Infinity Pharmaceuticals. She has worked at Sunovion Pharmaceuticals, the National Institutes of Health, and the Food and Drug Administration; she received her Ph.D. in Pharmacokinetics from the University of Maryland.