HPLC in FDA Warning Letters
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Recommendation
12/13 September 2024
In the current compilation of Warning Letters issued between 2009 and 2011 we have summarised for you the key points regarding the use of high performance liquid chromatography (HPLC).
The inspection focuses can be summarised and compiled in the following 4 themes:
- Raw Data / Protection of Electronic Records
- Calibration / Qualification
- Method Validation
- System Suitability / Sequences
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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