Biologics process development establishes manufacturing processes designed to consistently deliver product of the required ...

In nearly all regions and industries, markets for products reflect the impact of globalization. The tactic of competing on price is increasingly giving way to a wider range of factors—including ...

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Apply SPC and Minitab tools to control variation, reduce waste and rework, improve product quality, strengthen decisions, and support regulatory compliance.Dublin, Sept. 29, 2026 (GLOBE NEWSWIRE) -- ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...

Every team in every organization is (or should be) focused on quality assurance. Whether someone’s work primarily impacts their fellow team members or a company’s customers, making sure a job’s done ...

Strictly speaking, if you have a rigorous quality process in place, there should be no reason for a discussion of rework. In fact, it might be said that rework is the result of not having rigorous ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. David Chisnall discusses how the CHERI ...

More than 300 quality inspectors have been added to the assembly line - Ford is testing a new quality inspection process at its Kentucky assembly plant. - The plant is responsible for building the ...