Qualification of Equipment Annex 1 Qualification of Liquid Chromatography Equipment

The present document is the first Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the Liquid Chromatography (LC) equipment qualification process. The core document “Qualification of Equipment” contains the general introduction and the Level I and II of qualification, common to all types of instruments. The present Annex 1 contains a general introduction and requirements for LC (HPLC and UHPLC) instruments. Level III and IV qualifications must be carried out being an ISO/IEC 17025 requirement. Requirements and (if applicable) corresponding typical acceptance limits given in bold should be applied; however other appropriately justified approaches are acceptable. Exemplary procedures provided in this document have non-binding character. They can be helpful to carry out the required qualification. Nevertheless, it is left to the professional judgement and background experience of each OMCL to decide on the most relevant procedures to be undertaken in order to give evidence that their LC systems are working properly and are suitable for their intended use.