The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance—Data Integrity and Compliance With CGMP Guidance—and exploring new areas such as continuous manufacturing. The Emerson Life Sciences team has a full program of forums,...
pharmaceutical manufacturing
Integrating Single Use Equipment More Easily with Control and Manufacturing Execution Systems
One of the trends in the biopharmaceutical industries that have taken root over the past decade and a half is the use of single-use, disposable equipment in the manufacturing process. Prior to their use, these facilities relied on inflexible, hard-piped equipment. An...
Trends in the Life Sciences Industry
For pharmaceutical and biotech manufacturers, trends in the market place are driving changes in the way they have historically operated their production processes. I caught up with Emerson's Michalle Adkins who shared these trends with me. She identified six major...
FDA Guidance for Data Integrity and Compliance
Author: Michalle Adkins In April 2016, the FDA issued Data Integrity and Compliance With CGMP Guidance for Industry. This is on the heels of a lot of related 483s, warning letters, and more severe actions with respect to this issue. There are some interesting things...
Deploying Syncade Manufacturing Execution System in a Non-English Language
Author: Jonathan Lustri I recently worked on a Syncade manufacturing execution system (MES) project where the system was deployed in Danish. Emerson executes all its projects with a global team and this one was no different. Our customer was Danish and we had team...
Accurate and Repeatable Measurements in Pharmaceutical and Biotech Manufacturing
A Pharmaceutical Manufacturing magazine study revealed that pharmaceutical and biotech manufacturers were challenged to achieve batch after batch repeatability. I came across a recently published whitepaper, Consistency and Repeatability Through Accurate Measurements....
Overcoming Pharmaceutical Continuous Manufacturing Challenges
Why is there a movement in the pharmaceutical and biotech manufacturing industries to consider continuous manufacturing over traditional batch manufacturing processes? A 2012 U.S. Food & Drug Administration presentation, FDA Perspective on Continuous...
Is Process Analytical Technology Rocket Science?
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...
Improving Data Management, Analytics and Flexibility in Life Sciences
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...
Optimizing Life Sciences Processes by Improving Data Integration
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...
Data Integrity for Compliance, Audit Readiness and Performance
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...
Advancing the Management of Data through Life Sciences Product Lifecycles
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...
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The opinions expressed here are the personal opinions of the authors. Content published here is not read or approved by Emerson before it is posted and does not necessarily represent the views and opinions of Emerson.