Reg Deviation

Can any one give 10 examples for deviation

Deviating the written procedure. (Plan or unplan)

  1. 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.
  2. Lesser batch size batch is manufactured.
  3. Higher batch size batches to be manufactured (scale up activity)
  4. 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)
  5. During calibration (HPLC calibration) right unit not selected when preparing sequence.
  6. LOQ is not established in line with SOP (Method Validation SOP).
  7. WS COA signed without completion of Characterization data.
  8. Backup of “xx” device (any electronic device like thermohygrometer etc) is not take as per frequency mentioned in SOP.
  9. 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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