Book Description
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Book Info
Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more.
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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