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what is meant by CAPA?what is the source for deviation
(unplanned) to occur, though the process developed by
standard validation procedures?
- 3 Answers
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- GSK GlaxoSmithKline, I also Faced
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Answer / sunita sarang
CAPA : Corrective action and Preventive acton.
Though the process is developed by standard validation
procedures there are chances of unplanned deviation like
sudden breskdown of the system.So always we have to
upgrade/ maintain the system to avoid deviations.
| Is This Answer Correct ? | 16 Yes | 5 No |
Answer / deepika singh, ipqa, navdeep b
Corrective action and preventive action. No process
deviation shall be permitted under standard validation
procedures, but if occur likedeviation in the grade of
active raw material could affect the process parameters and
other critical quality attributes of formulation.
additional testing and revalidation should justify such
deviations
| Is This Answer Correct ? | 2 Yes | 0 No |
Answer / chandrashekhar tripathi
The CAPA in known as Corrective action and preventive action :
Deviation should be permitted under written standard procedure
and the process is also developed by as per standard validated
Procedure. If sudden occur breakdown or other type problem which may affect quality as per standard parameters then it will be Unplanned Deviation .
| Is This Answer Correct ? | 1 Yes | 0 No |
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