Can any one give 10 examples for deviation
Deviating the written procedure. (Plan or unplan)
- Plan : Similar reactor (but not mentioned in BMR) to be used during manufacturing of batch.
2 Unplan: Material X Y and Z not put in process as defined for example: Charge X after that Y and then Z. - Lesser batch size batch is manufactured.
- Higher batch size batches to be manufactured (scale up activity)
- Temp. goes up during batch manufacturing {(like temperature maintaining activity) (it can also be consider under incidence if temperature is critical and mode of evaluation to be different)
- During calibration (HPLC calibration) right unit not selected when preparing sequence.
- LOQ is not established in line with SOP (Method Validation SOP).
- WS COA signed without completion of Characterization data.
- Backup of “xx” device (any electronic device like thermohygrometer etc) is not take as per frequency mentioned in SOP.
- Calibration of instrument in not done in given tolerance limit (For example: Calibration to be done in six month ±7days (7 days are tolerance limit) but it was performed before/after 7 days).
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