Search results for " system"
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As this new class of biologic medicines is introduced into healthcare systems worldwide, there must be an uncompromising commitment to patient safety, which starts with high regulatory approval standa…
Article
Essentials in Quality Risk Management
ICH, Q10 Pharmaceutical Quality System (ICH, 2009).
5. ICH, Q11 Development and Manufacture of Drug Substances (ICH, May 2012).
6. FDA, PAT—A Framework for Innovative Pharmaceutical Developmen…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Implementing the infrastructure of a QbD approach to process development involves formalizing the commitment and the strategy and integrating execution into quality systems. The end result is a road m…
Article
Quality by design for biotechnology products—part 1
Quality by Design (QbD) is a concept applied to the design and development of biopharmaceutical molecules and manufacturing that entails building quality into the process and product in a systematic, …
Resource
World Health Organization
The World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shap…
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