May / June 2023

Technical

In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The key to data integrity compliance is a well-functioning data governance system1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised...
Technical

We will show how continuous, real-time capturing of data with immediate data analysis by an ML algorithm can improve control over a critical quality attribute. The ML-analyzed data provides the evidence for validation of the change by demonstrating more control over the process along with a decrease in process risks.

InTouch

“Over the past 20 years, there have been an increasing number of highly potent materials handled within the pharma industry, to the point where most modern products require some degree of containment or other exposure control to maintain safety,” said guide team member Peter Marshall, AstraZeneca (retired).

InTouch

Terry Jacobs is Chair of the Oral Solid Dosage (OSD) Community of Practice (CoP) Steering Committee. He is a recognized expert in the design of pharmaceutical, biotechnology, and corporate facilities and has completed projects for clients in the US, China, Mexico, and Saudi Arabia. He has lectured extensively on the planning and programming of laboratories and manufacturing and other...

InTouch

Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee. He is also Chief Quality Officer at Evive Biotech, responsible for all aspects of quality for the company, ensuring safety and efficacy, making critical quality decisions, and keeping the company up to date with new regulations. RJ became interested in the pharmaceutical...

InTouch

As Head of Merck’s Global Manufacturing Operations and one of the most senior operations leaders in Merck, Sanat is responsible for Merck’s worldwide manufacturing operations and product supply, supporting global sales revenue of over $55 billion.

Features

The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. This article offers an overview of the chemistry, manufacturing, and controls...

Insights

ISPE’s Emerging Leaders (EL) Steering Committee is taking time to get our foundation right so that we can help drive change and empower young pharmaceutical engineering professionals to pursue their dreams. Our vision and mission will serve as the pillar for how we engage with Emerging Leaders and students around the world, stay true to our goals, and adapt to regional requirements.