Customers enjoy buying from a small business that consistently delivers great products. However, the experience may last only a short time: Only two out of four small businesses survive beyond five ...

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 ...

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 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 ...

As an industrial engineer and digital transformation leader, I’ve worked across regulated industries—defense, aerospace and healthcare—where quality and compliance are paramount. Over the past few ...

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

Good managers seek to contain costs in the manufacturing environment. There is no better cost to eliminate than the cost of poor quality. Scrap material and lost labor hours add no value to 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.