ABSTRACT

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 exter

chapter 1|18 pages

CLEANING OBJECTIVES

chapter 2|24 pages

CLEANING AND CLEANING AGENTS

chapter 3|30 pages

CLEANING METHODS

chapter 6|16 pages

CLEANING CYCLE DEVELOPMENT

chapter 7|14 pages

GROUPING STRATEGIES

chapter 8|16 pages

SETTING ACCEPTANCE CRITERIA

chapter 9|18 pages

ANALYTICAL METHODS FOR CLEANING VALIDATION

chapter 10|24 pages

SAMPLING METHODS FOR CLEANING VALIDATION

chapter 11|12 pages

MICROBIAL ISSUES IN CLEANING VALIDATION

chapter 12|12 pages

CHANGE CONTROL AND REVALIDATION

chapter 13|16 pages

SPECIAL TOPICS IN CLEANING VALIDATION

chapter 14|14 pages

FDA EXPECTATIONS