Search results for " knowledge"
Article
Selecting the Right Viral Clearance Technology
He hopes that companies will continue to be forthcoming with their viral clearance knowledge and experiences as a means to demonstrate to the agencies and to the public the industry’s commitment to pa…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
In conjunction with effective policies and expanded use of standards and best practices for cell culturing and authentication, knowledge of why and how often to perform cell authentication will improv…
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The uncertainty factor often outweighs any available data or knowledge and typically drives the need for a low occurrence rating in manufacturing prior to setting the (final) control strategy.
Reg…
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USP Stresses Pharmacopeial Standards at CPhI China
“We will strengthen our collaboration with the Chinese Pharmacopoeia Commission and other partners to share knowledge on pharmacopeial standards, promote industry developments, and improve public heal…
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Quality Systems Key to Lifecycle Drug Management
Field inspection is not connected to knowledge gained from product review, and there can be a significant disconnect between clinical batch data and commercial production.
CDER’s new Office of Pharm…
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A Bright Future for the Plasma Fractionation Industry
The advantages of this QbD approach were claimed to be better information for process design, clear justification of the process and product specifications, and well-structured process and product kno…
Article
Quality by Design and Extractable and Leachable Testing
Change of the design space may occur after gaining additional process knowledge.
QbD principles allow for a more useful extractable and leachable program. Rather than simply focusing on identifi…
Article
Technologies and Practices Must Evolve to Meet Demand
Barriers to implementation remain; almost half of the respondents cited a lack of knowledge or training; 39% noted a lack of clarity on regulatory guidance; more than 25% noted a lack of management bu…
Article
Securing the Single-Use Supply Chain
“The role of the supplier is therefore now more critical, and regulators expect drug manufacturers to mitigate any risk with close partnerships and thorough knowledge of their suppliers’ quality syste…