CHANGE CONTROL


CHANGE CONTROL:
A procedure to evaluate,document approve and implement the changes to the existing approved procedures or accepted practices.
                                               or
The procedure which process,review,verifies,manages,approves and controls the changes made of the existing system,facility,process,procedure,document,product or any

changes in existing
1.process
2.parameter
3.batch size
4.products
5.raw material
6.start material
7.packing material
8.shelf life
9.storage conditions
10.additional processing
11.facility

Types of change control:

1.Temporary changes
2.Permanent changes
1.Temporary changes:
Any changes from documented procedure, process, system opted deliberately for temporary period to manage unavoidable situation or improving the performance of the operations, without affecting the quality and yield of the drug substance and safety of the operations shall be termed as temporary change. 

2.Permanent changes:
Any changes from documented procedure, process, system permanently as a part of continuous improvement of quality systems or to meet customer/ regulatory requirements.

Once this change is approved  and made it effective, then old documents or procedure will become obsolete.

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