Formats for change control , deviation & categorization of changes.
1) Do not retain this form and forward to the next after completion of review.
2) Put N/A where not applicable.
3) Attach an additional sheet if required as annexure.
4) Please specify the details in case of “others”.
Where UPD stands for Unplanned Deviation & PD stands for Planned Deviation,
XXX stands for Dept. Code, for ex. QA, QC, PRD, ADM, WH etc.
NNN stands for sequential no. of change control
YY stands for last two digits for the current year, for ex. 19 for 2019
RA: Regulatory Affairs (RA) approvals are required for changes to process filed in DMF. So in
case if there is no submission then QA – Head is authorized to sign in place of RA.
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