Analytical methods ensure quality of drugs and biologics. During last 2 decades, paradigm for quality of pharmaceutical products has shifted from ensuring quality by testing representative samples to building quality during manufacture of such products, leading to the concept of Quality by Design (QbD). This course starts with discussing the new paradigm of quality, QbD, and role of analytical methods in ensuring quality.
Methods play a critical role in development and manufacture of drugs and biologics and should be considered as a "Life Cycle" approach throughout the life cycle of a pharmaceutical product. The methods must be suitable for intended purpose during different stages of development and for commercial manufacture of the product. Understanding regulatory expectations and requirements for the methods is important to develop and design methods that are not only suitable for intended purpose, but support manufacturing operations in release of the product in a timely manner. All methods used in manufacturing operations must be maintained in a compliant state with acceptable method performance during life cycle of the product. This course will go into details of the life cycle of analytical methods, including verification, qualification and validation of methods for various stages of product development and for various purposes during manufacturing operations. Appropriate methods attributes and parameters will be discussed that need to be monitored (tracking and trending) to evaluate method performance.
Biologics products being complex and of biological origin, often require biological methods to release starting materials, intermediates and final product. Biological methods or bioassays with large inherent variability have challenges in developing appropriate method so that these are suitable for intended purpose. Focus on science and regulatory expectations during product development is essential to develop appropriate biological methods. This course will further go into the challenges, regulatory expectations and myths about bioassays with focus on developing suitable bioassays for intended purposes.
Upon completing this course the participants will understand:
Who Will Benefit:
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