Provides an overall view of designing cleaning programs in pharmaceutical process manufacturing settings, establishing residue limits, and selecting appropriate sampling and analytical procedures. Most of the examples given in the book involve simple cleaning systems, such as the cleaning of a process vessel. The book begins with cleaning agents, cleaning methods, process parameters, cleaning cycle development and grouping strategies, then discusses issues related to validation including microbial control and change control. The final chapter reviews FDA expectations for cleaning validation. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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.
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