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Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines? This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.
1st edition 2018
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Excerpt from the GMP Compliance Adviser Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines? And are you already familiar with the new requirements for establishing limits in cleaning validation? Michael Hiob, a German Ministerial Pharmaceutical Director and former GMP inspector, gives a comprehensive overview on agency expectations and tells you how to set up a risk-based cleaning validation in consideration of the lifecycle approach for products and processes. Dr. Jens Hrach, toxicologist, explains what the new PDE approach is about and points out its implications for cleaning validation. Cleaning validation is not new, but the official requirements were updated in the revised Annex 15 in order to reflect the current state of the art. Three aspects are in the foreground:
The Pharma Guide to Cleaning Validation will show you exactly what 'done correctly' is. The report includes:
Every page offers practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.
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