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By Lime on Tuesday, June 8, 2004 - 05:28 am:
Hi,
I have to change the brand name on my validated HPLC method. Should i study all validation parameters again or .... ?
thank you,
Lime
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By Lime on Tuesday, June 8, 2004 - 06:06 am:
* sorry there is a missing part in the other message !
Hi,
I have to change the column's brand name on my validated HPLC method. Should i study all validation parameters again or .... ?
thank you,
Lime
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By tom jupille on Tuesday, June 8, 2004 - 10:58 am:
I believe the FDA's position is that changing the brand of column amounts to a "modification" of the method. If the method is modified, it must be revalidated (yes, this means studying all the validation parameters again).
If you're using a USP method, you can use an "equivalent" column, but you have to demonstrate equivalence. In practice, this usually means simply demonstrating that you meet the system suitability criteria. Many labs will revalidate in any case, just to be on the safe side.
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By Anonymous on Tuesday, June 8, 2004 - 04:03 pm:
Was the company bought-out, and just will have a different name on the same column? Or is the column unavailable now so you have to use an alternate? If first, just state that supplier changed name. If second, I would at least show equivalency of samples run on both, I doubt that stuff like linearity would really be necessary. But then again, look at what else the feds spend money on....
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By Anonymous on Tuesday, June 8, 2004 - 05:16 pm:
In my view, if the column has the same specifications (or mostly the same) you would need to revalidate specificity. This is the parameter that most directly relates to the use of a different column. It's debatable, but accuracy could be revalidated again as well. I can't see why you would need to do more than that.
Hi,
I have to change the brand name on my validated HPLC method. Should i study all validation parameters again or .... ?
thank you,
Lime
-------------------------------------------------------------------------------------------------------
By Lime on Tuesday, June 8, 2004 - 06:06 am:
* sorry there is a missing part in the other message !
Hi,
I have to change the column's brand name on my validated HPLC method. Should i study all validation parameters again or .... ?
thank you,
Lime
-------------------------------------------------------------------------------------------------------
By tom jupille on Tuesday, June 8, 2004 - 10:58 am:
I believe the FDA's position is that changing the brand of column amounts to a "modification" of the method. If the method is modified, it must be revalidated (yes, this means studying all the validation parameters again).
If you're using a USP method, you can use an "equivalent" column, but you have to demonstrate equivalence. In practice, this usually means simply demonstrating that you meet the system suitability criteria. Many labs will revalidate in any case, just to be on the safe side.
-------------------------------------------------------------------------------------------------------
By Anonymous on Tuesday, June 8, 2004 - 04:03 pm:
Was the company bought-out, and just will have a different name on the same column? Or is the column unavailable now so you have to use an alternate? If first, just state that supplier changed name. If second, I would at least show equivalency of samples run on both, I doubt that stuff like linearity would really be necessary. But then again, look at what else the feds spend money on....
-------------------------------------------------------------------------------------------------------
By Anonymous on Tuesday, June 8, 2004 - 05:16 pm:
In my view, if the column has the same specifications (or mostly the same) you would need to revalidate specificity. This is the parameter that most directly relates to the use of a different column. It's debatable, but accuracy could be revalidated again as well. I can't see why you would need to do more than that.
