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Change control procedure: A formal controlled documented process
by which qualified representatives from appropriate discipline, review,
propose and make changes to an approved system.
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Temporary change:
A change initiated for the evaluation of proposed system /
procedure which has been taken with prior approval to achieve the desired
goal and allowed for one time change
& limited to a particular batch.
For example, the change in batch size,
Equipment , part dispatch of batch
etc.
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Permanent change: A
change initiated based upon scientific rational or historical GMP data or
data generated through temporary changes.
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Thursday, 14 November 2013
Change control types in Quality Assurance system
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