This book provides a step-by-step guide for building an effective program of cleaning validation, helping businesses define objectives, set policy, and allocate the proper resources to help avoid product contamination. Bismuth and Neumann, both professionals in the pharmaceutical industry in Israel, also discuss types of contamination, levels of cleaning, and the recommended procedures, materials, and tools necessary to develop a program acceptable to both US and non-US regulatory authorities. Annotation c. Book News, Inc., Portland, OR (booknews.com)
Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.
