Which types of deviations are followed in pharmaceuial API
manufacturing industry?
Answer Posted / sunil sharma (joping)
Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure.
There are two types of Deviations
Planned deviation and Unplanned deviation
Planned deviation: Planned deviation shall always be approved before execution of deviation.The documentation (before approval) should include the parameters to be monitored during execution of deviation.The quality of final output shall be checked & compared with regular process.
While closing the deviation, it should be evaluated for effectiveness, whether the purpose of taking deviation is achieved/not. If not, such deviation in future shall be avoided.
If the deviation is as per the exception the same can be considered for regularization.
After briefing on all the above points deviation shall be closed.
Unplanned Deviation: Any deviation occurred unplanned manner due to system failure or system breakdown or manual error shall be termed as Unplanned deviation
Is This Answer Correct ? | 0 Yes | 0 No |
Post New Answer View All Answers
What interests you about the position of Medical Librarian in our company?
What is the basic requirement for preparing drug master file , like EDMF , USDMF ?
from hplc chromatogram how can we say that calibration is needed now?
please e-mail me the model of Tamil Nadu drug inspector question papers
when i come in contact with any metal items or clothes of fur i find myself shock and when run my fingers on fur clothes or matters, i find sparks. Is there any vitiams deffecieny in my body. If so, what i have to do?
when we connect the capacitor banks in series with the circuit? 2 144 pH is having unit?
What do you mean by GTT? What are the effect of GTT on film coating.
how many clauses are there in iso? give me the clauses details?
What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan
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...
what is the mechanism of action of local anaesthetics?
Can any one tell me that which brand hplc column is used for levetiracetam imp- b test.
concomitant administration of 6-mercaptopurine and which product results in severe bonemarrow suppression?
What r the different sop in or plant
while formulation of Gliclazide floating tablets why we are using direct cmpression technique why not wet granulation and what happend with that