Rounded rules and complies

Discussions about methods, troubleshooting and best practices across both pharmaceutical and biopharmaceutical analysis.

4 posts Page 1 of 1
I received a complaint. The first of this type after many years of work.
Specification limit: ≤ 0.4 %

Result 0.42%

Is it compliant in your opinion? Or not?
if spec were written 0.40, there's an issue. Your result is in spec (barely), tell the complainer to rewrite the spec w/ justification if they want 0.42 to be OOS.
I agree with DR. Within specifications.

Had it been written as Specification limit: ≤ 0.40 %, then would be OOS.
I also agree with DR. To avoid this type of complaint, fix your report format to round the required number of digits...
4 posts Page 1 of 1

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