Retrospective validation of analytical instruments

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hello to all,

I want to know about retrospective validation study of analytical instuments like HPLC and FTIR etc… what will be the sample size in this study?

Thanks

Imzee2

2

Retrospective validation is to see the out put from the procedure i.e collective data of different parameters.

Let me know what is the meaning of sample size.

3

Dear Mr. Raval

Thank you very much for your reply, sample size means, how many testing events or as you said ?“outputs” will be included in this study ? Suppose we are going to validate HPLC , how many proudct analysis will be taken or can we do this on period basis like analysis done in last three months.

can you give me any web address for guidelines, or if u can share your experiance?

Regards