21 CFR 211.194 (a) (2) states..."The suitability of all testing methods used shall be verified under actual conditions of use". Most of the routine test methods (>99%) run at Irvine are USP monograph and general chapter test methods. Irvine has been in business for 22 years and has been performing USP methods since inception.
USP also states that general chapters with numbers 1000 and higher are recommendations or guidelines but are not enforceable. In addition most USP compendial methods have system suitability requirements that must be met prior to reporting out any test results.
USP <1226> states "The intent of this chapter is to provide general information on the verification of compendial procedures that are being performed for the first time to yield acceptable results utilizing the personnel, equipment, and reagents available. This chapter is not intended for retroactive application to already successfully established laboratory procedures".
A particular USP method may not work for every sample matrix manufactured; therefore, method verification can be sample specific.
Irvine's policy on this subject is that if the client wants Irvine to verify a USP method for their sample material, then a protocol needs to be written which requires the client's input as to what parameters will be verified (specificity, precision, etc.) and a quote for the work will be sent out indicating the agreed upon requirements according to the data elements required for validation in table #2 in <1225>.
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