Gil Bismuth,
Shosh Neumann
Cleaning Validation
A Practical Approach
Paperback Engels 2019 9780367398927Levertijd ± 8 werkdagen
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Samenvatting
Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.
Specificaties
ISBN13:9780367398927
Taal:Engels
Bindwijze:Paperback
Aantal pagina's:200
Uitgever:Taylor & Francis Ltd
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Inhoudsopgave
DEVELOPING A CLEANING PROCEDURE . Contamination Control. Regulatory Requirements. Cleaning Basic Concepts. Cleaning Procedure. DEVELOPING A CLEANING VALIDATION PROGRAM. Cleaning Validation Policy. Contamination Acceptance Limits. Cleaning Validation Planning & Execution. Cleaning Validation Monitoring & Maintenance. Special Cleaning Validation Issues. Cleaning Validation Trends. Appendices: Cleaning & Cleaning Validation Procedures. Cleaning. Cleaning Validation.
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