Deviation control

IN which conditions we approve the deviation

Dear Srivinas,
If the deviation fall in minor degree (non-critical) and it doesn’t make impact of product or process, then these deviation can be accepted and approved.

thanks for u r reply

We approved the deviation when this can not affect the producd quality, safety and efficacy of the product.

yeah , it is called less or non critical deviations.

Dear srinivas

What about the critical deviations.

Dear Lala,

In case of critical deviations, the level of impact should be assessed before going to deviations. In case the deviation is surely going to affect the Product Quality such deviations cannot be accepted at any circumstances. If your impact assessment reveals that with suitable CAPA, it wll not affect product quality can be accepted, still continous monitoring of the process is required & it should be documentaly eviedent that product quality is not afected. And atlast such Batches should be subjected for post impact assesment also.


  1. If your SOP defines that every departure from approved procedure should be dealt with deviation and CAPA should be defined, how we should not approve such deviation.

  2. If Deviation occurred in unplanned event how do you deal with the departure.

Suggestions appreciated…



Every deviation to be investigated,CAPA to be derived and concluded with conclusion of the batch status ( whether to accept the batch or to reject the batch) by the investigation team.

Based on the investiation details and conclusion, QA can approve the report and take release / not release decision.


after getting from CAPA, if the same deviation was repeated again. then what???