WHO TRS (Technical Report Series) 1025, 2020 Annex 4

WHO TRS (Technical Report Series) 1025, 2020 Annex 4

Good chromatography practices

1. Introduction and scope:

1.1 The use of chromatography methods such as high-performance liquid chromatography, also referred to as high-pressure liquid chromatography (HPLC), and gas chromatography (GC) in quality control laboratory analysis has increased significantly in recent years. Observations during inspections have shown that there was a need for a specific good practices (GXP) document.

1.2 HPLC and GC methods are used in, for example, the identification of materials and products, for determination of assay and related substances in materials and products, as well as in validation such as process validation and cleaning validation. Note: Although thin-layer chromatography methods are also used, this approach is not specifically addressed in detail in this document.

1.3 Owing to the criticality of the results obtained through chromatography, it must be ensured that the data acquired meet ALCOA+ principles (i.e. attributable, legible, contemporaneous, original and accurate, with additional emphases [see Glossary]).

1.5 This document provides information on GXP to be considered in the analysis of samples when chromatographic methods and systems are used. The principles should be applied in the analysis of, for example, raw materials, starting materials, intermediates, in-process materials and finished products.

1.6 The principles contained in this guideline are applicable to general chromatographic analysis used in, for example, assay determination, testing for related substances and impurities, process validation, cleaning validation, cleaning verification and stability testing.

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Table of Contents

WHO TRS (Technical Report Series) 1025, 2020 Annex 4:

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