Hi,
I am having an issue with management about a USP method.
We have a method to assay Menthol for Chromatographic purity using the GC and a USP standard Catalog # 1381709 . This is not the method listed in the current USP monograph. Can we use our own method using the USP standard to test the menthol for the chromatographic purity or do we have to use the USP method listed?
Every other tests we are using USP method except for Chromatographic purity which we are using our own method with a USP standard. The USP method does not use a standard.
I am sure i am correct that we can use our own method but management wants a reference in the USP or ICH relating to my discussion where an outside method can be used.
[quote=pidluk]Hi,
I am having an issue with management about a USP method.
We have a method to assay Menthol for Chromatographic purity using the GC and a USP standard Catalog # 1381709 . This is not the method listed in the current USP monograph. Can we use our own method using the USP standard to test the menthol for the chromatographic purity or do we have to use the USP method listed?
Every other tests we are using USP method except for Chromatographic purity which we are using our own method with a USP standard. The USP method does not use a standard.
I am sure i am correct that we can use our own method but management wants a reference in the USP or ICH relating to my discussion where an outside method can be used.[/quote]
[attach]508[/attach]
See the section 6.3 of the attachment(alternative procedures).
If you change USP method, Then the method should be validated and equivalance or betterment should be justified.
If the USP method is not available. you can use your own method(In-house) and this should be validated.
Method validation/verification(Specified in WHO guidance)
Method validation is conducted where non-compendial analytical
methods are included in the application to confirm that the applicants’
proposed analytical methods are suitable for regulatory purposes. A
side-by-side comparison with a compendial method, if available,
should be included. Method verification is conducted where the methods
are compendial, to confirm whether the product as compounded
can be analysed satisfactorily by the official method.
see the second page of the below attachement[ method validation/verification]
[attach]509[/attach]