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Solving the Challenge of High pH Injectable Drug ProductsClick HerePackaging Solutions for Sensitive Molecules
Solving the Challenge of Single-Use Large-Volume Delivery for Patient Self-Injection
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Regulatory SupportWest Regulatory Affairs provides a single point of contact to assist with global registration strategies for all West products and processes.Regulatory SupportKnowledge CenterThe West Knowledge Center provides scientific insight and more detailed technical information on key areas of expertise featuring technical reports, bulletins and science posters.Knowledge Center
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Challenges

Solving the Challenge of High pH Injectable Drug Products
Click Here

Solving the Challenge of Single-Use Large-Volume Delivery for Patient Self-Injection
Support
Regulatory Support
West Regulatory Affairs provides a single point of contact to assist with global registration strategies for all West products and processes.
Regulatory Support
Knowledge Center
The West Knowledge Center provides scientific insight and more detailed technical information on key areas of expertise featuring technical reports, bulletins and science posters.
Knowledge Center
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The West Blog
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December 02, 2013
Why is QbD so Confusing?
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
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