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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 Posted / 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.
| Is This Answer Correct ? | 74 Yes | 26 No |
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