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Commissioning and qualification (C&Q) are crucial in pharmaceutical manufacturing to meet regulatory standards. The ISPE Baseline Guide highlights the importance of integrating C&Q activities for compliance and product safety. Here, we focus on four stages of the C&Q lifecycle: requirement, design, verification, and quality decision.
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Quality by Design (QbD) emphasizes a strong understanding of both pharmaceutical products and the development process. Analytical Quality by Design (AQbD) extends QbD principles to analytical method development. Gain insight into the benefits of AQbD, current hurdles, and the major steps required for a successful AQbD implementation.
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Continuous manufacturing can reduce plant footprint as well as capital and labor costs while offering greater scalability, efficiency, and flexibility compared to traditional batch processing. Uncover how automation and real-time monitoring across all process steps provide the rapid response and control needed for successful continuous manufacturing.
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Explore a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement. Learn how digital platforms can streamline the application and how digitalization provides the scalability needed to apply this framework broadly.
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