Search results for " regulatory" in Articles / App Notes
Article
Supply Chain Challenges for Single-Use Systems
…irector of Life Sciences at Entegris; and Helene Pora, vice-president of Technical Communication and Regulatory Strategy at Pall about some of the issues facing the industry as companies look to SUS …
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Miniaturization to Become Even More Successful
Industrial bioprocess development has changed significantly in the last decade, driven primarily by two major factors: ever-rising R&D costs of developing therapeutic candidates with simultaneous de…
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Understanding Validation and Technical Transfer, Part 2
Development, process engineering, production, and regulatory affairs departments should almost always be involved. Other departments that might have input are purchasing, warehousing, and compliance. …
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CoAs Help Secure the Supply Chain
Schniepp, distinguished fellow at Regulatory Compliance Associates
Damian Palus/Shutterstock.com
Q. I work in the warehouse and am responsible for maintaining the pape…
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Modern Manufacturing Key to More Effective Vaccines
To keep pace with accelerated clinical testing of potential Ebola preventives, FDA collaborated with other regulatory authorities and WHO to gain convergence on key issues, such as exceptions to produ…
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Reliability Rooms and the Move to Proactive Supply Chain Management
This is based on a supply chain that can deliver these new products to customers following regulatory approvals and in the committed timeframe.
As RRs develop, they remain centered around four k…
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Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…
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Best Practices for Data Integrity
In regulatory jargon, this means you want your computerized system to be ‘open’.
In addition, validate. Auditors won’t believe the system behaves as expected when you use it unless you …
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Fusion Proteins Pose Manufacturability Challenges
Early in 2017, for instance, Celgene acquired Delinia, which is developing DEL106, a novel IL-2 mutein Fc fusion protein designed to upregulate regulatory T cells (Tregs). Roche/Genentech is focused o…
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Being Thorough When Transferring Technology
The technology transfer procedures implemented are typically guided by International Council for Harmonization (ICH) Q10 or equivalent guidance from other regulatory authorities. This guidance is prac…