Full, partial and cross Validation

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

Can some one explain the difference between partial validation, method verification and cross validation and when it is requried. i have done the full validation when method is newly developed.

  1. If i am using USP Method without making any changes at all do i need to validate it (full or partial)?
  2. What if i use all the usp method parameters but use a different colum ?
  3. Is mthod verification is same as method transfer ?
  4. I do not have any idea about cross validation.

Thanks

2

[quote=vjp]Can some one explain the difference between partial validation, method verification and cross validation and when it is requried. i have done the full validation when method is newly developed.

  1. If i am using USP Method without making any changes at all do i need to validate it (full or partial)?
  2. What if i use all the usp method parameters but use a different colum ?
  3. Is mthod verification is same as method transfer ?
  4. I do not have any idea about cross validation.

Thanks[/quote]

Dear VJP
Partial validation is done with limited parameters like Specificity and Precision repeatability, for the same product with different strengths. Method Verification is done for a pharmacopeal method. That requires Specificity and precision repeatability plus three lot verification.
I think there is one chapter in USP for column equivalency for Chromatographic method, anyways i ll check and will let u know.

3

Thank you shahid

4

You are always welcomed!!!