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ICH Q1, local validation not required?

Phil_Kay

Hi,

A question from a biopharma customer and their QA department:

“is JMP off-the-shelf- software compliant to ICH Q1 guidelines for expiration dating, hence local validation not required?”

Does that make any sense? Or do we need to ask more questions about their question?

Thanks,

Phil

@Byron_JMP @Chris_Kirchberg @statpharmer

Accepted answers

Jeff_Perkinson

Please refer customers to our Quality Statement (JMP.com/qualitystatement). For questions about a customer's regulatory or legal obligations for testing, validation, or certification we are not in a position to provide guidance or advice beyond what is found there.

That statement has been vetted and approved by our legal department.

All comments

Jeff_Perkinson

That statement has been vetted and approved by our legal department.

Mark_Bailey

I worked with Peng during the development of the Stability Analysis in Degradation while I was writing the Stability Analysis training course with Heath Rushing. It implements the recommended analysis per the ICH guidance.

Furthermore, Peng made sure that the results exactly match those of a popular SAS macro commonly sued for determining expiry according to the guidance.

Hope this background helps.

Phil_Kay

Thanks, @Mark_Bailey . That is helpful. That is what I thought.

But we should not answer the question about "local validation not required". They need to answer that themselves.

Cheers,

Phil

Mark_Bailey

Sorry I missed that part. You are correct. While SAS can help to an extent with our exterior quality systems as Jeff pointed out, the user must still validate their specific use of JMP (e.g., proper installation, appropriate model, valid assumptions, clean data, and so on). We cannot on our own guarantee that JMP is valid in every case.

Phil_Kay

Yes, thinking about it, you could read their question as an attempt to get us to state that they don't need to validate. That is, take the responsibility to ensure compliance away from them. And we clearly don't want to get involved in that!