please help me how to investigate this OOS " as per monograph talc has three nm-1, at first instance one of the three did not matched. when repeated by the same analyst two of the three nm-1 are not matched. when repeating by another analyst all the containers are passed but in the composite one of the three nm-1 not matched". please if any one have any thought please share with me how to investigate and how to resolve.
Results Variation in between the analysts means there is analyst error…
If any material does not comply as per specifications, that the repeat analysis results should be resemble with initial results…If the repeat analysis results not matches means there might be error during the analysis, check the functioning of the instrument, if it within the validated state…then suspicion during the sampling / sample preparation…