difference between temporary change control and deviation
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Answer / amit kumar
In Short,
Deviation is an unplaned change
Change Control is a planed change afetr assessing the
impect on the other functions.
| Is This Answer Correct ? | 22 Yes | 7 No |
Answer / abhishek morris
Deviation means departure from any approved procedure
unknowingly same like incident, and temperory change means
changing the approved procedure on temperory basis after
risk analysis and evaluation by cross fuctional team.
| Is This Answer Correct ? | 11 Yes | 0 No |
Answer / ramesh
Deviation is an unplanned change and the change is for
particular batch of product.
But change control is perminent change is for ever.
| Is This Answer Correct ? | 9 Yes | 5 No |
Temporary change control and deviation
Change control: It is a documented procedure wherein we can make changes in an approved procedure, process, equipment, method for better improvement without impacting the product quality and before implementing such changes, approval of Quality unit must be needed.All the changes made through change control procedures are PERMANENT, they are not TEMPORARY.
Deviation: There are two types of deviations
Unplanned: It is the situation where we did not follow the written procedure which is against cGMP. in such cases a deviation is need to be filed and investigation must be done and accordingly CAPA must be taken.
Planned: It is the situation where we can not follow the written procedure due to technical problem and we must deviate the procedure to process further. such planned deviation must be minor in nature and are for TEMPORARY only. Before making any planned deviation, Impact assessment shall be done. If we want to make such changes permanent then change control procedure must be used.
or we cannot follow (planned) the approved procedure to p
| Is This Answer Correct ? | 3 Yes | 1 No |
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