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Validation Master Plan for SVPs by Anzari Muhammad is a document available to read on EtoBox.

What is Validation Master Plan for SVPs about?

This document is a validation master plan for the small volume parenterals production line at Fresenius Kabi. It begins with an introduction to regulatory guidelines on process validation from the FDA and EMA, including concepts like traditional validation, continuous process verification, and quality by design. It then characterizes the small volume parenterals production process and identifies critical quality attributes and critical process parameters. Finally, it performs a process analysis to evaluate

Author

Anzari Muhammad

Language

EN