Cleaning Validation - A Practical Approach

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.

List of contents

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.

About the author

Bismuth, Gil; Neumann, Shosh

Product details

• Authors: Gil Bismuth, Bismuth Gil, Shosh Neumann, Neumann Shosh
• Publisher: Taylor and Francis
• Languages: English
• Product format: Hardback
• Released: 31.01.2000
• EAN: 9781574911084
• ISBN: 978-1-57491-108-4
• No. of pages: 200
• Weight: 530 g
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Non-clinical medicine; SCIENCE / Chemistry / General, MEDICAL / Pharmacology, Biology, life sciences