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 ...

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 ...

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.

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Birgitta Böckeler, Distinguished Engineer at ...