Answer / nitin

deviation is not permant but change control is perment

Answer / rambabu komati

deviations are two types one is planned deviation and
another is un planned deviation. Planned deviations are two
types one is tempery and another is permenent. tempery
deviations are approved by QA then u proceed. permenent
deviations are must be reviewed by releated departments and
approved by QA through change control procedure.

Regards,

Rambabu

Answer / yatin ajgaonkar

Change control is a planned activity to bring about changes
in document/process/method.It can be for shorter period of
time or it can be permanent. It must be intimated to all
the concerned departments for official approval of Change
Control.
Deviation is an aberration from the given procedure which
is done intentionally or unintentionally. A deviation can
be divided into critical & non critical. Effects of
critical deviations should be assessed through
investigation & Corrective & Preventive Actions.

Answer / ashish saxena

DEVIATION MEANS - YOU ARE NOT FOLLOWING THE WRITTEN
DOCUMENTED PROCEDURS-MEANS U HAVE ALREADY THE SYSTEM FOR
HANDLING PARTICULAR THING OR EVENT BUT U R NOT FOLLOWING IT
MAY BE PLANNED OR UNPLANNED
BUT IN CASE OF CHANGE CONTROL U R CHANGING THE PROCEDURE
COMPLETLY STATING THAT THE CHANGED PROCEDURE IS THE FINAL
DOCUMENTED PROCEDURE AND ANY VIOLETION FROM IT IS TREATED
AS DEVIATION

Answer / vipin

Deviation is temporary and it is two types one is plan
deviation another is unplaned deviation. Unplaned deviation
is occure suddenly.

Change controle is a proposal that change in any
process,equipments or method. But it approved the comments
of all department which are related to this change.

Answer / atul asthana

There are two typpes of deviation one is minor and anaother
is critical, minor deviation is approved by QA where as
Critical Deviation are filled by Concerned departments with
Corrective and preventive Action, than it is reviewed by
Head-API and R&D and put their comments and finally
reviewed and approved by QA for any particular Batch.

Change Control Proposal denotes any permanant and temporary
change in process/equipements or method and before raising
the CCP it should be data oriented along with proper
Justification and Corective and preventive action.If
changes are critical than technical group i.e.President and
Regulatory Head are also involved for this.

Answer / 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

Answer / sanjeev kishore

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 consective
deviations which is approved by the concerned departments
ane authorised by QA.

Answer / ankur sharma

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 consective
deviations which is approved by the concerned departments
ane authorised by QA.

Answer / mukesh tiwari

Change control is documentary evidence for approval,
rejection and implementation any process, system or new things.
Requirements of CC: when initiating any new thinking this
is approvment the existing system.
Deviation: Departure from writing down procedure, system
which is design during initially stage.

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