Overview of Available Guidance Documents

There are numerous guidelines which outline the regulatory aspects of HPLC analysis available on the internet. Table 4 represents some of the regulatory authorities and their associated websites. 

This chapter reviews the principles and strategies used for HPLC system calibration that includes the pump, the detector, the autosampler, and the column oven. A case study is used to illustrate the development of the calibration procedures for all system modules and the rationale of setting up acceptance criteria that balance productivity and compliance. 

In this chapter, the principles and strategies behind HPLC calibration are described and illustrated with a case study of a company s revised calibration procedures and acceptance criteria. 

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