what is meant by CAPA?what is the source for deviation
(unplanned) to occur, though the process developed by
standard validation procedures?
- 3 Answers
- 9998 Views
- GSK GlaxoSmithKline, I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
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 |
Which is the best Institute for Clinical Research, Clinical Data Management and Pharmacovigilance in Hyderabad?
difference between RF and correction factor?
how many deviation allowed
human body absorbs maximum amount of nutrients in
Iam a B.PHARMA GRADUATE from DELHI UNIVERSITY and I am looking forward for DRUG INSPECTOR EXAM..kindly mail me any ques papaers reg the same...
difference between related substances and purity?
1 Answers Micro Labs, Zydus Cadila,
concomitant administration of 6-mercaptopurine and which product results in severe bonemarrow suppression?
How do you fix the known and unknown impurity limit for a drug substance?
are vaccines for long term or short term?
2 Answers GSK GlaxoSmithKline,
Caffeine standard is recommended by the monograph for HPLC wavelength accuracy calibration. It is covered range of 205 to 273 only.If the method have wavelength beyond the range, then how it supports for instrument performance?
what is meant by CAPA?what is the source for deviation (unplanned) to occur, though the process developed by standard validation procedures?
3 Answers GSK GlaxoSmithKline,
pls send me last two years solved papers of health & malaria inspector to kumar.santosh087@yahoo.com
Pharmacy 
