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 ...

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 ...

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

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 ...

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 ...

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.

Within software product development, quality engineering and quality assurance are often lumped together. However, these practices are far from synonymous. Quality assurance can be considered a part ...