Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits.

Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

Contents

1. Cleaning Objectives
2. Cleaning and Cleaning Agents
3. Cleaning Methods
4. Process Parameters in Cleaning-Part I
5. Process Parameters in Cleaning-Part II
6. Cleaning Cycle Development
7. Grouping Strategies
8. Setting Acceptance Criteria
9. Analytical Methods for Cleaning Validation
10. Sampling Methods for Cleaning Validation
11. Microbial Issues in Cleaning Validation
12. Change Control and Revalidation
13. Special Topics in Cleaning Validation
14. FDA Expectations

Appendices

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