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buffer changing after method validation
Posted: Mon Aug 12, 2019 4:20 pm
by jay_dabhi
We are currently working on method validation project for protein therapeutics.
Is it possible to change formulation buffer being used while method was validation earlier? In what situation, we can go for replacing the old buffer with new ?
Re: buffer changing after method validation
Posted: Tue Aug 13, 2019 11:08 pm
by tom jupille
Is it possible to change formulation buffer being used while method was validation earlier?
The short answer is "no". The method must be validated as written. If you change the buffer midway through the validation, the relevant portions must be revalidated.
In what situation, we can go for replacing the old buffer with new ?
Per the above comment, changing the buffer is a "modification" of the method. A modified method must be revalidated.
Re: buffer changing after method validation
Posted: Wed Aug 14, 2019 3:11 pm
by jay_dabhi
Thanks, Tom,
If I want to change matrix from Serum to PBS in a validation study for Poloxamer HOLC assay, then can I go for only limited revalidation only Or I have to revalidate each parameter? The method was previously validated with serum as a matrix. Changing Serum to PBS gonna have any big impact on validation study? I think to go from complex to the simpler matrix, the validation wouldn't have any big impact. We have very limited time to get the method ready with new buffer and that's why I am looking for limited revalidation.
Re: buffer changing after method validation
Posted: Sat Aug 17, 2019 12:16 am
by tom jupille
I think to go from complex to the simpler matrix, the validation wouldn't have any big impact.
What you (or I) *think* is irrelevant. The only way to *know* is to run the validation. That's what validation is all about.
Can you take shortcuts? Of course you can, but you are taking a risk. Just ask the engineers at Boeing whether you should.