By pro on Tuesday, January 23, 2001 - 01:27 am:
A question : when to validate an official USP/Ph.Eu/BP HPLC/potentiometric method ?
By chromgod on Wednesday, January 24, 2001 - 08:28 am:
.....before you report results of such measurements as related to product quality/conformity.
By Anonymous on Thursday, April 26, 2001 - 04:38 am:
You don't have to validate compendial methods. The compendial method (ie USP, EP method) is already accepted by the FDA as being validated. The FDA sees such sources of methods as the "analytical bible". All you must do is perform a laboratory qualification.
By pro on Friday, April 27, 2001 - 12:55 am:
Please, what do you mean for "laboratory qualification" ?.
Is it something like IQ OQ PQ ?
Thanks.
By Olivia on Friday, April 27, 2001 - 02:07 am:
According to FDA's draft guidance issued in August 2000:
"The suitability of a compendial analytical procedure must be verified under actual conditions of use (21 CFR 211.194(a)(2)). Information to demonstrate that USP/NF analytical procedures are suitable for the drug product or drug substance should be included in the submission.
Information on the
- specificity,
- intermediate precision, and
- stability of the sample solution
should be included."
By pro on Friday, April 27, 2001 - 02:45 am:
So, if in my submission for a drug substance that, according its USP analitical, provide also a potentiometric assay method, I include all Chromatographyc matter validation
(linearity, specificity, LOD, LOQ, stability testing etc...), shall I demonstrate anything about the potentiometric assay ?
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