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 ...

Process understanding also extends beyond regulatory compliance. Greater visibility into process performance can improve ...

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 ...

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

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 ...

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 ...

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 ...

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 ...

Poor quality management can place a permanent stain on any project. To avoid this, the project manager must first determine how the client or the project sponsor defines quality–and then follow suit.