Change control management in Pharma

In procedure of change control following activity

·        Identification of the changes

·        Proposal of changes with proper justification

·        Review of and evaluation of change control 

·        Approval of  change control

·        Action plan for the activity to be performed after approval

·        Implementation of  changes

·        Verification of changes

·        Closing of change control

Identification of the change:

If any change is identified or may be the change is required for the better system in to the established system or the facility. It shall be identified the User or concern department  

Proposal of changes with proper justification:

After Identification of the change control proposal with proper justification its supportive data change control shall be initiated. For the initiation of the change control change control form shall be issued from the QA department .for proper justification reference of Guideline or rational data are required

Review of and evaluation of change control ,

After initiation of the change control it shall be evaluated by the QA person after proper assessment it shall be concluded that how this change is impacted to other department .For impact of the change to other department also evaluated and identified.

Approval of change control:

After proper evaluation of change control it shall be reviewed by the QA head and after review of available data and action change control shall be approved or rejected by the QA head.

Action plan for the activity to be performed after approval

If change control is approved by the QA head action plan shall be prepared for execution of the changes. Proper action  plan is required to better execution of the changes .

Implementation of changes :

After proper action plan .All activity /document shall be performed as per plan. And it shall be properly implemented

Verification of changes :

After implementation of the changes it shall be verified whether it is properly implemented or not .Proper implementation must be required to complete the purpose  

Closing the change control:

After proper implementation it shall be closed by the QA-Head with proper required supportive data.


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