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NK ☆ India, 2025-04-10 09:54 (16 d 10:34 ago) Posting: # 24399 Views: 539 |
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Dear All, According to ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis, Step 5, Section 4.3.2, which outlines the acceptance criteria for an analytical run: "Calibration standards from a failed batch cannot be used to validate or accept other batches within the same analytical run." Please explain the statement, with respect to the acceptance of multiple batches in below scenario If, within the analytical run, calibration standards are accepted in the first batch but QC samples in the first batch fail to meet acceptance criteria, subsequently second and third batches QC samples meet the acceptance criteria. Whether the acceptance of subsequent, Multiple/distinct batches (the second and third) within the same analytical run is considered valid. Thanks and Regards NK |
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Ohlbe ★★★ France, 2025-04-10 14:27 (16 d 06:01 ago) @ NK Posting: # 24401 Views: 416 |
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Dear NK, ❝ If, within the analytical run, calibration standards are accepted in the first batch but QC samples in the first batch fail to meet acceptance criteria, subsequently second and third batches QC samples meet the acceptance criteria. ❝ ❝ Whether the acceptance of subsequent, Multiple/distinct batches (the second and third) within the same analytical run is considered valid. If you only have calibration standards in the first batch: no, your calibration curve is not considered valid, you have to fail the whole run. If you also have calibration samples in the 2nd and/or 3rd batch (e.g. front and end calibration curves), and the samples in these batches are sufficient to built a calibration curve meeting the requirements of the guideline, section 3.3.2: you can reject the first batch but accept the others, if their QCs pass. — Regards Ohlbe |
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NK ☆ India, 2025-04-15 05:30 (11 d 14:58 ago) @ Ohlbe Posting: # 24403 Views: 313 |
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Dear Ohlbe, Thank you for your response. Regards NK |
Ing. Helmut Schütz