Industry Insights
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Best Practices For Multisite, Concurrent Rollout Of Manufacturing Execution Systems
7/28/2017
The current expansion in manufacturing execution system rollouts in life sciences has led to a number of challenges with regard to multisite concurrent rollouts and how to achieve them in a timely manner.
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What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?
5/2/2017
This article presents the most recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency). The CDER data and the MHRA data come from GMP inspections conducted in 2016.
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21st Century Cures & FDA Implementation: 5 Important Takeaways For Biopharma Companies
12/21/2016
Now that the 21st Century Cures bill has been signed into law — following a nearly three- year journey that included a fair number of detours and roadblocks — all eyes in the drug development world are shifting to FDA. To the question “What now?” FDA can answer: A great deal of work.
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Sterile Injectable Therapies: Revolutionizing Lifecycle Management
The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.
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Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market
9/26/2016
With the U.S opioid analgesic addiction and overdose crisis showing no signs of relenting, change is coming fast for manufacturers of chronic pain drugs.
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Approaches To Improve Efficiency In Biopharmaceutical Process Development
5/5/2020
Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. These tools make process development more efficient.
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The EU’s Biopharma Industry Can Deliver More With IDMP Data Standards
12/17/2021
Promises abound in the IDMP software industry about the vast transformation potential of data-driven processes beyond pharma regulatory exchange. Biotechs, unencumbered by legacy systems and processes, could blaze a trail. This article provides the steps to take now.
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How To Use Quality Metrics To Measure And Improve Training ROI
1/4/2018
Part 1 of this two-part article described a framework design for calculating training program ROI using ISPE quality metrics. This installment will explain how to execute such calculations and how to implement an ROI plan to set and achieve goals that meet specific business objectives.
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Building A Productive Relationship With The FDA: Beyond The Science
5/17/2017
At the end of the day (or several years), sponsors and the FDA ideally work collaboratively during the drug development process, having a shared public health goal of making safe, effective, and high-quality drugs available to the American public as quickly as possible.
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Implementing Single-Use At Bioprocessing’s Core
5/20/2016
Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. One of the biggest drivers in the current evolution of biological facility design is the implementation of single-use systems (SUS).