The discipline of Cleaning Validation is as individual as process validation, but the methods, techniques and risks are almost identical in all kinds of pharmaceutical manufacture.

A smooth technology transfer and successful Cleaning Validation in the manufacturing plant can optimize time to market for a new product.

Topics included in the Cleaning Validation Handbook:

• Development of a Cleaning Process
• Cleaning perspective for Clinical Trials manufacture
• Pharmaceutical Cleaning: A comprehensive Approach
• Cleaning Validation in the Pharmaceutical Industry

Topics included in Cleaning Validation, Special Edition Volume I:

• Cleaning Validation Programs: How to Get Started
• Cleaning Validation from a Laboratory Perspective
• Establishing Acceptance Criteria
• FDA Enforcement Practice
• Cleaning FDA-483 and Warning Letters
• And much more!

Topics included in Cleaning Validation, Special Edition Volume II:

• Equipment Cleaning Validation for Transdermals
• How to Solve Complex Cleaning Validation Problems
• Establishing Cleaning Verification Acceptance Limits for Clinical Operations
• Your Cleaning Program: Is It Ready for the Pre-Approval Inspection?
• And much more!

Topics included in Cleaning Validation, Special Edition Volume III:

• Equipment Cleaning Validation: Microbial Control Issues
• A Cleaning Validation Master Plan for Oral Solid Dose Pharmaceutical Manufacturing Equipment
• Control and Monitoring of Bioburden in Biotech/Pharmaceutical Clean rooms
• Total Organic Carbon analysis for cleaning Validation in Pharmaceutical Manufacturing
• And much more!