Validation of Computer-Based HPLC Systems

GMP News No. 538

GMP News
1 April 2005


 Validation of Computer-Based HPLC Systems

Many lectures and publications point out that the article of the former FDA representatives Furman, Layloff and Tetzlaff titled
"Validation of Computerized Liquid Chromatographic Systems", published in 1993, is one of the most important early publications on the topics of qualification of HPLC systems and validation of chromatographic systems. Even though this publication is more than 10 years old, meaning that it was written before 21 CFR Part 11 became effective in the US, it has not become less important. This is certainly also the reason why the article was included in FDA's website only a few months ago and is now accessible to everyone. The complete document can be found here:

This publication differentiates between "modular validation" on the one hand and "holistic validation" on the other hand. Modular validation nowadays refers to those tests that are carried out during operational qualification within the scope of the qualification of single modules. Holistic validation focuses on the operating mode of the entire system and corresponds today to the performance qualification of HPLC systems.

Two additional tables show further suggestions on the practical implementation. Another focal point is the storage and saving of raw data. In this context, of course, "floppy disks" do not represent the state of the art any more.

The validation of computerised HPLC Systems is one of the key topics at the GMP Education Course "Successful HPLC Management in a GMP-/FDA-regulated Environment" which takes place on 21-22 September 2005 in Copenhagen, with a subsequent workshop on the "Validation of Chromatographic Data Systems (CDS)" on 23 September 2005. Please click here to find the complete programme.

Dr Günter Brendelberger


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