What are the validation/verification requirements for an FTIR method used to release a raw material?: This is an ID method (non compendial) looking to confirm the location of 4 specific bandwidths in the raw material spectra .confused:
According to ICH Q2(R1), only specificity to be proved for identifications tests. Same guideline states that “The identification test may be applied to materials structurally similar to or closely related to the analyte to confirm that a positive response is not obtained”. So, prepare the FTIR disc (sample) using analyte and see the response at the specified bandwidths. Conduct the same test with structurally related impurity of your analyte and the spectra should not show the response at the specified bandwidths. Now, prepare the disc with mixture of analyte and impurity and see the response at the specified bandwidths. The spectra should show response at specified band widths.
Regards
Veerraju
thanks Veerraju - appreciate the response
Welcome…
Just another quick question . Have to validate a method that monitors the max tempature generated during a polyimerisation reaction. We use a standard thermocouple approach. I have classified this as a class III method in accordance with usp (1225). As it is a performance characteristic. Therefore requiring an assessment of precision. Would you agree?
I didn’t understand your case clearly. “Polymerization reaction” means one of the manufacturing steps and USP 1225 is “validation of analytical methods”. so i’m little confused. if you can elaborate your question, i will try to provide my best suggestion…
The method is actually a finished product release test. This is a bone cement product, the method is based on ISO 5833- annex c- max temperature and setting time. I am finding it challenging to apply standard method validation requirements to these applications as the methods look at performance characteristics of the product, temp, setting time, compression strength of the reacted product…
I can give more info if you like…
I think i understand your case now. your opinion is correct. you can consider it as category III test and need to prove its precision only.
Reference for Revalidation.
Click on the below link, it is WHO Reference document
Regards,
Bujjireddy.k
9676749937
I have a question:
we have an FTIR which we bought 1n july 05 2011, we did a complete IQ/OQ on it, which was good for one year in july 05 2012 we supossed to do calibration again… we did calibration in July 20 9 after 1 year and 15 days). is this 15 days considered to be a gap in calibration of our FTIR and basically if the validation is done for one time how long it is still valid? do we have to do validation or calibration on a frequent basis and if yes,what is the frequency.
Please advise
Thank you
Dear LAN
I didn’t find the exact guideline for your query. But, according to terms and definitions mentioned in ISO 14644-1 (Clean room guidelines), 12 months means “up to 400th day” and “the average (of X years) should not exceed 366 days”. Means, as you have done 15 days late to the scheduled period, try to do 15 days earlier (on or before June 20, 2013) next year
VEERRAJU
[quote=ramyaraj725]Dear LAN
I didn’t find the exact guideline for your query. But, according to terms and definitions mentioned in ISO 14644-1 (Clean room guidelines), 12 months means “up to 400th day” and “the average (of X years) should not exceed 366 days”. Means, as you have done 15 days late to the scheduled period, try to do 15 days earlier (on or before June 20, 2013) next year
VEERRAJU[/quote]
Thanks Ramyaraj