Cleaning Validation


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About The Book

<p>Pharmaceutical manufacturers and upper management are encouraged to meet the</p><p>challenges of the science-based and risk-based approaches to cleaning validation.</p><p>Using some of the principles and practices in this volume will help in designing a</p><p>more effective and efficient cleaning validation program.</p><p>Features</p><p>• Timely coverage of cleaning validation for the pharmaceutical industry</p><p>a dynamic area in terms of health-based limits.</p><p>• The author encourages pharmaceutical manufacturers and particularly</p><p>upper management to meet the challenges of the science-based and riskbased</p><p>approaches to cleaning validation.</p><p>• Draws on the author’s vast experience in the field of cleaning validation</p><p>and hazardous materials.</p><p>• Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for</p><p>highly hazardous products in shared facilities.</p><p>• A diverse list of topics from protocol limits for yeasts and molds to</p><p>cleaning validation for homeopathic drug products.</p>
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