Hello!! You have a rational to indicate the maximum number of failures attributable to various batch for identification with raman technique?
The Raman spectrophotometer should have an IOQ (wavelength accuracy…) The analytical method should have been validated per ICH Q2. Thus, NO failures are acceptable! Start a deviation under CAPA and perform an investigation (including an OOS and LIR).
it is very difficult . especially they quano arrive 100/200 parcels to be identified
Yes! No failures! You can use statistics and a subset of the lot to obtain a 99.0% probability (or better).
Which is? I can indicate SOP that 99 % of packages must pass on the first try ? And for those that do not pass ?
%Yes! Your method (Raman) must be validated (the accuracy is up to you). Lots that fail your specifications (accuracy) MUST be rejected! And always use a decimal point (significant digits) per USP general notices (page 4) thus 99% is 99.0%
Remember. Your ‘analytical method’ is your yardstick. If your yardstick is broken, What do you trust???