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For method validation the criteria need to be defined and documented.
These are the major points to consider:
a. Purpose of measurement (why?)
b. Any sample matrices involved?
c. Any interference expected?
d. Expected concentration ranges or levels
e. Any specific environment conditions?
f. Type of instrument and/or equipment for assay performance
g. Type of cleaning equipment (automatic, manual )
h. Construction of the cleaning equipment (glass, stainless steel,. polypropylene, polycarbonate, polyethylene)
i. Reagents and chemicals with defined composition and purity
j. Methods used for preparation of calibrators and reagents
k. Calibrators (standards) and Controls (low, medium and high within the range of calibration curve
l. Use of calibrated instrument(s) and accessories (e.g., pH meter, pipets, balance etc.)
m. Chemicals and reagents with defined purity and composition
n. Stability of prepared reagents for the assay
o. Sampling plan (replicates)
p. Written assay procedure
q. Any regulatory requirements?
