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What is the GMP-compliant approach and what do the single steps in the process flow look like? Our pdf download picks up these questions and gives a concise overview of the OOX process.
1st edition 2015
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Excerpt from the GMP Compliance Adviser How to deal with OOX Results Despite the aura of sensitivity surrounding results outside defined criteria, correct and confident handling of these types of results is crucial and can be used during audits to demonstrate high quality standards. A structured approach also provides very valuable information to improve the standard of quality. What is the GMP-compliant approach and what do the single steps in the process flow look like? The pdf download Industry Guide to handle OOX Test Results - Managing Test Results out of Defined Criteria picks up these questions and gives a concise overview of the OOX process. It deals in detail with the following issues:
Our author Dr. Markus Limberger gives answers to the following crucial questions:
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