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GMP-Conform Sampling and Handling of Substances
1st edition 8/2019
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Excerpt from the GMP Compliance Adviser
This e-book provides you with the basic information you need - many illustrations, examples, tables and checklists enable you to quickly familiarise yourself with the topic.
Quality control has an important function in ensuring drug quality. In the laboratory, not only drugs, but also starting materials and packaging materials are tested for compliance with their specifications. Representative sampling and the use of validated methods are prerequisites for meaningful results. Whether the results are "correct" depends on many factors: standards and reagents must be of a defined quality and analytical instruments must function perfectly.
In this e-book you will find regulatory requirements, methodological principles and practical implementation proposals on the following topics:
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This file is in PDF format!Filesize: 5,78 MB
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