This chapter is taken from the book Cleaning and Cleaning Validation, Volume 2

Bill Hall discusses the differences between traditional cleaning and the cleaning requirements for API manufacturers. He includes regulatory requirements, the initial risk-assessment as well as the entire cleaning program.

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About the Author

William E. Hall, Ph.D., is an internationally recognized expert in the field of pharmaceutical cleaning and cleaning validation.With more than 50 years experience, he has developed many of the techniques and concepts used in the industry today. He has published widely, is an accomplished teacher, and has received numerous awards over the years. As consultant, he has worked with more than 500 companies worldwide and has influenced many cleaning programs. He also teaches cleaning concepts to the FDA and serves as an expert witness to the FDA, in litigation proceedings.