Regular acceptance criteria

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

I am new to this field.
If I need to set up a validation protocol, and the impurity they want to be less than 1%, it already comes to LOD. what do yiou think I can set the acceptance criteria RSD for it. is there any guidline for this?

2

[quote=julietinmay]I am new to this field.
If I need to set up a validation protocol, and the impurity they want to be less than 1%, it already comes to LOD. what do yiou think I can set the acceptance criteria RSD for it. is there any guidline for this?[/quote]

Can you please elaborate your Q?

3

Dear Mam
For RS type Method LOD is not Required

4

Yes RSD limit for RS Replicate injection u can keep is 5.0% and for assay replicate injection u can keep 2.0%