More than a decade ago, the U.S. Food and Drug Administration published, Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. In this document, the FDA explained: The scientific, risk-based framework...
Pharmaceutical and biopharmaceutical manufacturers are challenged on many fronts, such as managing regulatory requirements, operating efficiency, and maintaining the right data required as part of the medicines and products produced. Emerson's Michalle Adkins was...
Pharmaceutical and biotech manufacturers face many economic and technical challenges including reduced prices and diminishing profits, rising research & development costs, increasing regulatory requirements and a greater need for optimized manufacturing...
Pharmaceutical and biotech manufacturers have stringent regulatory compliance requirements. These requirements must balance with the need for improvement and optimization to run safely, efficiently, profitably and in line with the business and quality objectives. In a...
From a recent Life Sciences symposium, we looked at issues in the advancement of process intelligence and analytics. Today we'll look at another work session from the symposium, Managing Data Through the Product Life Cycle. The general session was led by Amgen's...
In a recent post, Collaborating for End-to-End Supply Chain Improvements, we highlighted a Life Sciences symposium where challenges to business improvements were discussed as inputs for technology and solution innovation to address these challenges. One of the...
You can hardly connect online without coming across articles about big data. Businesses are grappling with how to use this information to improve their businesses—from upfront marketing and sales through improving the efficiency of the supply chain and optimizing...
For pharmaceutical and biopharmaceutical manufacturers, there are a lot confusion around the concepts of design space (DS), Process Analytical Technology (PAT), and Quality by Design (QbD). Emerson's Zuwei Jin believes that this confusion has largely limited the...
The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and...
The Emerson Exchange conference October 6-10 in Orlando, Florida USA is rapidly approaching. I caught up with Emerson's Michalle Adkins who mentioned that her team of Life Sciences consultants would be highlighting the enablement of release by exception. Although...
In 2011, the U.S. Food & Drug Administration (FDA) published their Guidance for Industry – Process Validation: General Principles and Practices. A PharmManufacturing.com article, A Framework for Technology Transfer to Satisfy the Requirements of the New Process...
In the 4:42 video, Life Science Drug Process Development and Manufacturing, Emerson's Gary Mitchell highlights the changes occurring for pharmaceutical and biotech manufacturers. Gary opens noting how these manufacturers are challenged to respond to new methods for...
We invite you to follow us on Facebook, LinkedIn, Twitter and YouTube to stay up to date on the latest news, events and innovations that will help you face and solve your toughest challenges.
Just post a link to the entry and send us a quick note so we can share your work. Thank you very much.
Our Global Community
Emerson Exchange 365
This blog features expert perspectives from Emerson's automation professionals on industry trends, technologies, and best practices. The information shared here is intended to inform and educate our global community of users and partners.