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- W609899135 abstract "Foreword Introduction THE REGULATORY REQUIREMENTS FOR VALIDATION IN THE PHARMACEUTICAL INDUSTRY The Regulatory Requirements of Good Manufacturing Practices (GMP's) The Relationship between Validation and the GMP's The Impact of Changing Regulations on the Scope and Extent of Validation The Future for the GMP's THE FUNDAMENTALS AND ESSENTIALS OF VALIDATION Validation Concepts, Definitions and Terminology The Philosophy and Key Principles of Validation Organizing and Planning for Validation The Essential Validation Disciplines THE PRACTICE OF FACILITY VALIDATION A Typical Life Cycle Approach for the Qualification and Validation of a Pharmaceutical Manufacturing Facility TWENTY TOOLS RECOMMENDED FOR FACILITY VALIDATION Common Problems associated with Facility Validation Good Validation Practices GOOD VALIDATION PRACTICES The Benefits of Following Good Validation Practices in Facility Validation Projects The Consequences of Not Following these Good Validation Practices CONCLUSIONS AND FUTURE DIRECTIONS" @default.
- W609899135 created "2016-06-24" @default.
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- W609899135 date "2004-03-29" @default.
- W609899135 modified "2023-09-27" @default.
- W609899135 title "Facility Validation: Theory, Practice, and Tools" @default.
- W609899135 hasPublicationYear "2004" @default.
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