Qualification of Atomic Absorption / Atomic Emission Spectrometers

EDQM has published a guidance for the qualification of Atomic Absorption / Atomic Emission Spectrometers.

The document is the tenth Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the Atomic absorption (AA) spectrometer/ Atomic emission (AE) spectrometer qualification process. For AE spectrometer only atomization in flame is considered (Inductively coupled plasma-atomic emission spectrometry is not covered by this guideline).

The core document contains the Introduction and general forms for Level I and II of qualification, which are common to all type of instruments and the present annex contains instrument-related recommendations on parameters to be checked at Level III and IV of qualification and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks.

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/)