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 ...

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 ...

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality. Routine, ongoing assessment of process performance and ...

In-process dimension checking very often is adding to production cost and no one knows it, besides which it can be inefficient while it silently eats into profitability. In Part 3 of this series we ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...