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RegisterEMA GL: Batch size in validation [Bioanalytics]
Hi HS,
To enable evaluation of any trends over time within one run, it is recommended to demonstrate accuracy of QC samples over at least one of the runs with a size equivalent to a prospective analytical run.
As per the statement we need to demonstrate the accuracy of the QC representing the sample size of the batch during the routine analysis. This means that, during your validation run the batch with samples equivalent to size of sample analysis. It doesn't mean that it should exactly matches the batch size during the sample analysis.
As per your example you have analyzed the 86 batches with 72-108 samples that was in one study. Let consider the study was carried for IR (Immediate release) formulation with two periods. if the same method is used for the study with ER (Rxtended release) formulation with three periods then the sample size of the batch will vary (sample size will be more...
).
So, I don't think again we have to prove for the accuracy of the QC's as the batch size is increased.
This is my opinion, if i am wrong please correct me.
Regards,
Vajra.
To enable evaluation of any trends over time within one run, it is recommended to demonstrate accuracy of QC samples over at least one of the runs with a size equivalent to a prospective analytical run.
As per the statement we need to demonstrate the accuracy of the QC representing the sample size of the batch during the routine analysis. This means that, during your validation run the batch with samples equivalent to size of sample analysis. It doesn't mean that it should exactly matches the batch size during the sample analysis.
As per your example you have analyzed the 86 batches with 72-108 samples that was in one study. Let consider the study was carried for IR (Immediate release) formulation with two periods. if the same method is used for the study with ER (Rxtended release) formulation with three periods then the sample size of the batch will vary (sample size will be more...
).So, I don't think again we have to prove for the accuracy of the QC's as the batch size is increased.
This is my opinion, if i am wrong please correct me.
Regards,
Vajra.
—
Vajra
Vajra
Complete thread:
- EMA GL: Batch size in validation Helmut 2010-06-10 14:43
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- EMA GL: Batch size in validation Helmut 2010-09-07 12:54
- EMA GL: Batch size in validationvajra123 2010-09-08 05:34
- EMA GL: Batch size in validation Helmut 2010-09-08 12:36
- EMA GL: Batch size in validation vajra123 2010-09-08 13:19
- EMA GL: Batch size in validation Helmut 2010-09-08 13:32
- EMA GL: Batch size in validation Ohlbe 2010-09-08 18:03
- EMA GL: Batch size in validation Helmut 2010-09-08 18:16
- EMA GL: Batch size in validation Ohlbe 2010-09-08 19:03
- EMA GL: Batch size in validation Helmut 2010-09-08 19:07
- EMA GL: Batch size in validation Ohlbe 2010-09-08 19:03
- EMA GL: Batch size in validation Helmut 2010-09-08 18:16
- EMA GL: Batch size in validation Ohlbe 2010-09-08 18:03
- EMA GL: Batch size in validation Helmut 2010-09-08 13:32
- EMA GL: Batch size in validation vajra123 2010-09-08 13:19
- EMA GL: Batch size in validation Helmut 2010-09-08 12:36
Ing. Helmut Schütz