EDQM has published a guidance for the qualification of Atomic Absorption / Atomic Emission Spectrometers.
The frequency of performing the checks should be defined by each OMCL. Level III (Periodic and motivated instrument calibration/checks) and IV (In-use instrument checks) qualifications must be carried out as an ISO 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 when carrying 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 provide evidence that their AA/ AE spectrometers are working properly and are suitable for their intended use. If the qualification of equipment is done by the manufacturer or an external service provider, it is the responsibility of the OMCL to make sure that this is in line with the requirements set out in this guideline.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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