what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control
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Answer / subhash chauhan cipla indore
Deviation is two type one is planned and second is unplaned
deviation planned deviation is also two type one is
temprory and second is permanent temperory is raised by QA
and permanent is raised by concern deparment,with approval
by department head,and deviation in we not follow the
written procedure,and change control is parmanant procedure
and it is approved by approved all department it directly
emapct on system,documentand system
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Answer / bhrigu narayan tiwari
Deviation is any depletion/deviation from written procedure/SOP.It's temporary.
Change is permanent.It's oldage phenamenon.It may be either temporary or permanant depend on nature of deviation.It shoud have changeing histry along with propr justification and CAPA and should be approved by technical head of respective department and Q.A. department.
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Answer / dushmant behera
Change control- Process to control change in documents, process and facility.
Deviation - Departure from a established standard procedure.
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Answer / sandeep gaikwad
Deviation is not permanent but change control is permanent.
Deviation is a process in which we have to perform a task
that is not mentioned in the SOP, Change control is a
procedure in which we have to make a permanent change in
the Document, procedure or method, by raising 3 consecutive
deviations which is approved by the concerned departments
are authorized by QA..
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Change control :is a planned deviation when any abnormality or inaccurate observed in the sop, stp ,process, method
fallowing can be addressed by change control process
EX:if ay chemist found that instead of ml printed as g
or
if any chemist observed that indicator in assay in the sop is methyl red instead of methyl orange
Deviation : is a unplanned activity when as activity was performed with out fallowing the approved document (Departure from an approved document)
fallowing can be addressed by deviation
Ex:if a analyst done the analysis by taking 1 g sample instead of 2 g
or
if a analyst selected a wrong method for the analysis of sample
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Answer / nilesh l patel
change control is a adition process of current and new process or method or equipments ,like: 1>new sop preparation 2> upgrade previous sop or method or process for better gmp complience.it may be tempery or permenant,and depends on requirement of perticular department through QA and intimation should be sent to all concern deparments for this change.
deviation is a process of changing product specificaton ,process,method through change control with permission of concern dept hod and QA AUTHORITY FOR THAT THEY GO THROUGH INVESTIGATON RESULTS, AND CAPA PROCEDURE.
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Answer / dixit kachhia
deviation-Departure from an approved instruction or
established standard.
change control- replacement of an approved instruction or
established standard.
diff is departure and replacement
if we want any replacement we can raise change control with
proper justification
any deviation should be reported is necessary
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Answer / dhana
Deviation is established procedure
deviation are two catagery,one is critical and other is non-critical
critical deviation-to direct impact the quality of product
non-critical deviation- no impact of quality of product.
Change control is planned activities.
Change control are two types
one is temperary and other is permanant
temperary change control under QA observation
permanant change control are must be reviewed by related department and finaly approved by QA
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Answer / jain
Deviation are not planed.. it is unplanned,
for planed deviation ist take temporary change in control are if it success and not effect on quality of product then it convert in to permanent change in control after approval of qa
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Answer / dipak mishrs
Deviation is departure of aney standard prameter from there approved and standard operating procedure.It of three tiype minor, majer and critical
Change control is define as.. if u are going to make aney change in document,process,method or equipment temprory or permanently in order to achiving better result from previous that.
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Explain photostability ?
what is the diffirence between deviation and change control? at what situations we can raise the deviation and change control
31 Answers Biocon, Cipla, DRL, Glenmark, Granules, Lupin, Micro Labs, Mylan, Natco, Ranbaxy, Swissmedic,
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