HPLC in FDA Warning Letters

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

All these topics and further important aspects of a GMP/FDA compliant use of HPLC in the GMP laboratory will be covered in detail and discussed in ECA's Education Course "Maximising HPLC Productivity" from 18 - 20 April 2012 in Prague. This event will be a great opportunity for you to prepare your HPLC lab for the next FDA inspection.

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)