Bioequivalence and Bioavailability Forum • EMA GL: Batch size in validation

EMA GL: Batch size in validation [Bioanalytics]

posted by Helmut – Vienna, Austria, 2010-06-10 16:43 (5862 d 12:44 ago) – Posting: # 5492
Views: 7,909

Dear all,

the draft guideline states in Section 4.1.5 Accuracy, lines 196-198:

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.

According to the EUFEPS/EBF-workshop last April I would expect that this statement will 'make it' to the final version.

We have one validated method (GC/MS stable isotope IS) which is in routine use for numerous years. Until now we have analyzed ~8300 samples and had not a single batch rejected (86 batches, size 72-108 study samples/batch, average 96 samples without calibrators/QCs). What do you think? Will regulators insist in performing a new validation run in ~110 samples or would it be sufficient to refer to historical data?

—
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Helmut Schütz

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Complete thread:

EMA GL: Batch size in validationHelmut 2010-06-10 14:43
- EMA GL: Batch size in validation Helmut 2010-09-07 12:54
- EMA GL: Batch size in validation vajra123 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