QP Stats

Question 1

When do you see statistics used as a QP and how are they useful to you?

Answer 1

Method validation
Process validation
Method transfer
Trending (environmental, finished product, stability, analysis (QC), process (production). KPIs)
Stability studies

Question 2

Describe a T-test?

Answer 2

confidence levels (analysis, e.g. assay) of a mean – systematic errors
comparing an experimental mean with a known value – significance test
comparing means of two methods – e.g. method transfer, new method, for systematic errors – significance test) – need pooled std deviation
using the standard error of the mean (SEM) to determine confidence levels of 95% - construct the equation for 95% confidence level (obtain t value from table) and check the null hypothesis (the two means are equal hence the methods give the same results) (NB: 95% confidence level that 95% of the sample means will lie in the range)

Question 3

What statistics do you use in comparing 2 sets of results from two separate laboratories?

Answer 3

T Test