Interested to Buy Any Domain ? << Click Here >> for more details...
what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control
- 31 Answers
- 167971 Views
- Biocon, Cipla, DRL, Glenmark, Granules, Lupin, Micro Labs, Mylan, Natco, Ranbaxy, Swissmedic, I also Faced
- E-Mail Answers
Answer Posted / santhosh matam
Deviation: Departure from the approved manufacturing
process/SOP/Systems shall be considered as a deviation
management system. This is an unexpected event occurring
which is out of control. The concept of Planned deviation
is wiped out long back. There is no planned deviation as
such. As planned deviation is a non compliance to the
approved process/SOP/Systems.
Change control System: Any change in the process/SOP/Systems
shall be changed from approved Change Control Procedure.
Change control procedure denotes permanent change and
temporary changes. After getting assessment from CFTs & QA,
change can be implemented by validating the procedures. If
there are any discrepancies identified at the
initial(Validation stage), immediately this can be revert
back to the original state by closing the change control and
stated as not approved. If found no discrepancy this
temporary change control shall be approved and converted
into a permanent change. Some change controls can be made
permanent when we know the
| Is This Answer Correct ? | 46 Yes | 5 No |
Post New Answer View All Answers
what is factor?
from hplc chromatogram how can we say that calibration is needed now?
what is the leak test procedure of filled bottles (liquid)
please e-mail me the model of Tamil Nadu drug inspector question papers
what is meant by artwork review and handling procedure with an example?
What is the role of buffers (ex: KH2PO4) in HPLC analysis,
what is your experience in medical continuing education.
Hi Sir?Mam, If i complete SAS CLINICAL in India, can i step forward to USA for job trials? How far is it possible? Am a B.pharm student ,willing to make up my Master's degree too,will this both M.Pharm and SAS help me out to get a job in USA? Please help me out with a good answer.
why nitrogen charecter as a inert gas plz identified
plz.mail me model papers of drug inspector of chhattisgarh..or MP.if Posible. Mail Id-recha_1428@rediffmail.com...mrs_1428@rediffmail.com,
WHAT IS MEANING OF DEAIATION WITH EXAMPLE
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?
Tell us about your oncology experience.
Can any one tell me that which brand hplc column is used for levetiracetam imp- b test.
How to do IR test of hydroscopic materials
