Hi all!
I have a question related to gage r & r. I have experience validating analytical methods according to pharmaceutical validation (USP, ICH), I work in a medical industries and it is dificult to explain to the engineers, they always want to see a gage r & r, does this gage applies to analytical methods? And if do so how do you performe it? Do you use samples or an standard solution?
I believe that Gauge R&R is a great test. If one is building automotive engine parts, and wants to measure crankshaft journals.
But I think it has little value for multi-step analytical chemistry test procedures. Our QA department got caught up with a PhD statistician and bought in to this for about two years. Let’s just say that pH measurement and oven solids did not meet the Gauge R&R requirements.
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Thanks for your reply!
I want to agree in this but I still can not understand, when you say requiremente, Do you mean samples, operators and repetitions?, we can have all of this in a analytical methods (chromatography, spectrophotometry)!
[quote=tirso]Thanks for your reply!
I want to agree in this but I still can not understand, when you say requiremente, Do you mean samples, operators and repetitions?, we can have all of this in a analytical methods (chromatography, spectrophotometry)![/quote]
Test Method Validation is typically MORE than Gage R&R.
Gage R&R is for precision. Specifically comparing the method precision to the process/entire system precision.
Test Method Validation encompasses precision (samples, operators, repetitions), and accuracy, linearity, limit of detection etc. There are many guidelines for method validation such as ICH, USP, PDA etc.
a significant difference between Gauge R&R and method validation is that…
in ICH-USP-PDAs, the acceptance criteria for method validation is an pretty much a rule of thumb (standardized RSD, +/- criterias which are almost pre-set viz., precisios - RSD for HPLC 2%, UV 3%, GC 15% etc.,)
and then we also get to hear common note that +/-3% is attributed to process variability!
on other hand R&R actually “compares” for actual performance of method vs system.
is any one in phama industry, actually performing to the letter and spirit of R&R?
In my experience in analytical method validation to asses the repeatability we test one samples, six time by the same technitian and we calculate a %CV, to asssess the reproducibility we make the same experiment (same sample) performe by a different technitian, solution and day.
I performed an experimet testing two different sample by duplicate, by two technitian using two different methods, here are the results:
Tech I, Method I, Sample I: %CV 0.29
Tech I, Method I, Sample II: %CV 0.26
Tech II, Method I, Sample I: %CV 0.65
Tech II, Method I, Sample I: %CV 0.56
Tech I, Method II, Sample I: %CV 2.01
Tech I, Method II, Sample II: %CV 0.93
Tech II, Method II, Sample I: %CV 0.19
Tech II, Method II, Sample II: %CV 0.32
from my point of view this would meet a validation requirement.
If I perform a Gage R&R both methods give me a contribution above 30%, so do not meet the requirements. Can someone help me to explain this? I triying to understand that use a gage R&R will be like apply this gage to a final product after 6 step production operation.
We would need more information on the what you’re testing and how you’re testing to be able to help.
[quote=tirso]Hi all!
I have a question related to gage r & r. I have experience validating analytical methods according to pharmaceutical validation (USP, ICH), I work in a medical industries and it is dificult to explain to the engineers, they always want to see a gage r & r, does this gage applies to analytical methods? And if do so how do you performe it? Do you use samples or an standard solution?[/quote]
Is there any other FDA registered/inspected that does TMVs for test methods (including methods that use test equipment) instead of IQ/OQ/PQ for the test method?
We have created and used for some years ago TMV protocol template and a TMV report template and they include:
- IQ elements and
- OQ elements and
- the actual MSA study (GRR, attribute studies etc.)
so we have the possibility (and have done this in the past) to do only such TMVs without having separate IQ & OQ documents for a test equipment but I’m wondering how FDA is looking at this (do they expect to have separate IQ/OQ nonetheless because they are so used to these terms, even for test equipment?).
regards,
sheikh