Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries covers the training involved in the development, manufacturing, auditing, and validation of pharmaceuticals on a pilot scale, leading to scale-up production.

Features:

• Supplies a basic education of cleaning validation
• Gives an advanced approach to validation professionals who are already in the field to implement and execute a thorough cleaning validation program
• Includes 23 easy-to-use template protocols for cleaning validation of extensively and most commonly used equipments, with sampling points identified through pictures
• Includes hands-on training based on current approaches and techniques, and gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols
• Covers a wide range of active ingredients, including their level of solubility in water and potency/toxicity so as to provide an easy way for validation professionals to create a worst-case matrix for different equipment
• Provides a complete tool to understand, learn, think, and implement a validation program

Additionally, the bookt includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary

Contents

1. How to Establish a Cleaning Validation Program
2. Introduction
3. Scope and Approach
4. Cleaning Validation Team Members and Responsibilities
5. Cleaning Validation Philosophy, Strategies, and Methodology
6. Planning Phase
7. Execution Phase
8. Analytical Testing and Reporting Phase
9. Equipment Description
10. Facility Description
11. Utilities Description: DIW, WFI, Steam, and Compressed Air
12. Utilities Monitoring and Microbiological Control
13. Equipment Cleaning Materials/Detergent Description
14. Microbiological Cleaning of Equipment Surface
15. Solubility of Active Materials in Water
16. Toxicity of Active Materials
17. Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS)
18. Product/Equipment Train Matrix (Tab–Cap–PPS)
19. Worst-Case Products (Tablets, Capsules, and PPS) Matrix
20. Validation with Corresponding Cleaning Procedures
21. Cleaning Validation Product Grouping Matrix (Syrup)
22. Cleaning Validation Product/Equipment Train (Syrup)
23. Worst-Case Products (Syrup)
24. Cleaning Validation Product Grouping Matrix (Suspension)
25. Product Grouping/Equipment Train Matrix (Suspension)
26. Worst-Case Products (Suspension)
27. Product Grouping Matrix (Drops)
28. Product/Equipment Train (Drops)
29. Worst-Case Products (Drops)
30. Cleaning Validation Product Grouping Matrix (Cream/Ointment)
31. Product/Equipment Train (Cream and Ointment)
32. Worst-Case Products (Ointment and Cream)
33. Product Grouping Matrix (Suppositories)
34. Cleaning Validation Product/Equipment Train (Suppositories)
35. Worst-Case Products (Suppositories)
36. Cleaning Validation Protocols Products (Suppositories)
37. Cleaning Validation Product Grouping Matrix (Sterile)
38. Cleaning Validation Product/Equipment Train Matrix (Sterile)
39. Validation Protocols Biological and Sterile Products
40. Cleaning Validation Tentative Plan (Schedule)
41. Cleaning Validation Sampling and Testing Status
42. Cleaning Validation Regulatory Guidelines
43. Sampling Tools

Index

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