Gil Bismuth, Shosh Neumann

Cleaning Validation

A Practical Approach

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 200
• Erscheinungstermin: 31. Januar 2000
• Englisch
• Abmessung: 260mm x 183mm x 15mm
• Gewicht: 583g
• ISBN-13: 9781574911084
• ISBN-10: 1574911082
• Artikelnr.: 21129320

Autorenporträt

Bismuth, Gil; Neumann, Shosh

Inhaltsangabe

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.