Validation of non chromatographic methods

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Hi Everybody,

I have a question for whoever can give me a help.
I have been requested to validate non chromatographic methods and, honestly, in some cases, it sounds very weird to me.
For example, one of the cases is KF or pH…
Have you ever come across such situations? If so, what is the best approach to do it?
On the contrary, if you feel some techniques don’t need to be validated, how can I support this thesis. I haven’t found anything about it on FDA or ICH websites.

can you please help me?

thanks a lot,

E.

2

I’m also have problem while running MV using non-chromatographic method for eg. AAS. Any one here can help me. Any website or info for non-chromatographic MV.

yatt

3

HI
regarding to validation of non chromatographic methods, I think pH do not need a validation it need instrument qulification and daily calibration and check (it just like analytical balances)
regarding to KF it need some development of your product (I suggest to prove that your time of mixing generate same results as a long time of stirring like 30 min) but no validation is required also cause you can detarmine the titrant conc. on analysis day and check it with sod. tartarate.
hope this help you

4

Yes, some equipment do not need any method validation but instrument qualification is necessary. eg. timer, pH, balance…
Often, many do get mix up with instrument/equipment qualifiaction and METHOD validation.
KF and AAS do indeed need method validation because a specific method is design for getting yr results. stirtime, reagents, accuracy in this sample matrix,…
Of course, before the method come into place, the instrumnet itself need to be qualified and fit for use in yr context. eg. sensitivity, calibration check,…

5

Hi u can very well validate ur non chromatographic method with following parameter.

  1. Specificity - For KF calcualte water content for sample and spiked water sample.

  2. Linearity - u can show linearity

  3. LOD AND LOQ - U CAN SHOW lod loq

and all parameter

6

Hi,
I very weel agree with chemtab

7

[quote=echolyn]Hi Everybody,

I have a question for whoever can give me a help.
I have been requested to validate non chromatographic methods and, honestly, in some cases, it sounds very weird to me.
For example, one of the cases is KF or pH…
Have you ever come across such situations? If so, what is the best approach to do it?
On the contrary, if you feel some techniques don’t need to be validated, how can I support this thesis. I haven’t found anything about it on FDA or ICH websites.

can you please help me?

thanks a lot,

E.[/quote]

Lets all be very clear about method validation and instrument qualification. Prior to method validation instrument must be qualified, analyst must be trained, Reference standard of known potency to be used and Written analytical procedure and proper approved protocol with pre-established acceptance criteria are required.

8

How about to validate thin layer chromatographic method. Some of my methods are using TLC so, how to validate TLC methods? Do TLC method can be validate?
Thanks