Pre-Requisites for Analytical Method Validation

Prerequisites is usually a checklist which is sent to the Receiving Laboratory which in most of the cases is the Quality control laboratory of the manufacturing.

This checklist is prepared by the Department or the team which is involved in the method validation/verification/transfer activity and contains all the things which are required and needed to be kept ready before starting the Analytical Method validation/verification/transfer activity at the receiving laboratory.

Following things are ideally included in the checklist:


Lists all the instruments which would be required for the activity eg. Analytical balance, HPLC, GC, centrifuge machine etc.


Lists all the Chemicals and solvents along with its grade which are needed, eg, Potassium dihydrogen phosphate, methanol-HPLC grade, Water-MilliQ, Dimethylformamide-GC Grade etc.


All the HPLC, GC, IC columns as mentioned in the method of analysis along with the part numbers for better traceability.


Reference/Working standards, GC-Grade standards, Primary standards which would be required for the for the analysis.


Impurities which are required for the AMV activity along with the Chemical names for better clarity.


Type of filters to be used for sample filtration like PVDF, Nylon, PTFE etc.

Any Special Detector

If the method specifies any special detector for HPLC-FLD, GC - TCD etc. which required for special analysis.

Any-other requirements

This section gives the details of all the things which are ae not listed above and that would be essential for analysis e.g. wide mouth volumetric flask, particular type of GC Liner etc.

On receipt of the checklist, the receiving laboratory needs to check and confirm the availability of all the requirements listed and submit the checklist to the sender laboratory.

The things which are not available at the receiving laboratory should be made available by the team/department involved in method development or evaluation.

The Tentative time required for the activity is also highlighted in the checklist.

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