Facility Validation: Theory, Practice, and Tools by Graham C. Wrigley

By Graham C. Wrigley

Focusing on validation matters particular to the start-up of a brand new or upgraded manufacturing unit, this ebook offers definitions of the guidelines, directions, and laws when it comes to sturdy production Practices (GMPs) in pharmaceutical industries around the world. the writer discusses the validation innovations, definitions, and terminology linked to GMPs and info the philosophy and key rules of validation. He demonstrates how you can manage an infrastructure for enforcing a validation application. integrated within the publication are sensible examples of validation files and SOPs, a complete word list of validation terminology, and insurance of top practices for comparing validation programs.

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