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 ...

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...

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 ...