Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book ...
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Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and coverage of best practices for evaluating validation programs.
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Add this copy of Facility Validation: Theory, Practice, and Tools to cart. $108.35, new condition, Sold by discount_scientific_books rated 5.0 out of 5 stars, ships from Sterling Heights, MI, UNITED STATES.
Add this copy of Facility Validation: Theory, Practice, and Tools to cart. $301.13, new condition, Sold by GridFreed rated 5.0 out of 5 stars, ships from North Las Vegas, NV, UNITED STATES, published by CRC Press.