HONOUR LAB LIMITED (UNIT-V)

CHANGE REQUEST FORM

CR No. : ______________________________ Date : ____________________
Unit : ______________________________ Department : ____________________
Product: ______________________________ Stage : ____________________

I. CHANGE INITIATION:
1.0 Change required in (Put √ mark)
SOP STP Document Equipment
Process Vendor / Supplier Others (Specify) ________________

2.0 Is the proposed change is : Temporary / Permanent (Put √ mark).

3.0 Existing Document No.: ____________________ New Document No. : ___________________
Existing Equipment No.: ____________________ New Equipment No.: ___________________
4.0 Change Type
Introduction Revision Deletion
5.0 Name of the requester : ________________________
Department : ________________________ Designation : ________________________

6.0 Description of the Existing procedure (Attach additional sheet (Form QA-006), if required):
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
7.0 Description of the proposed change (Attach additional sheet (Form QA-006), if required):
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
8.0 Reasons for the proposed change (Attach additional sheet (Form QA-006), if required):
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
9.0 Supporting information / justification for the change proposed (Attach if required):

Form No. : QA-004-00 Effective date :

Reference SOP No.: Current version of 20-002 Next review due :

Prepared by:___________ Reviewed by : _________ Reviewed by: _________ Approved by: _________
Date : ___________ Date : __________ Date : ___________ Date : __________
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HONOUR LAB LIMITED (UNIT-V)
CHANGE REQUEST FORM
CR No.:________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
10.0 Impact assessment (Impact on immediate areas/activity/procedure) of proposed change
(Attach additional sheet if required):
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
Change requested by : __________________ Date: _________________
Head of the department: __________________ Date: _________________

II. IMPACT ASSESSMENT

11.0 Quality Assurance Actions :
11.1 Is the proposed change Major or Minor : _____________________
(Put √ mark)
YES NO NA
11.2 Stability studies required
11.3 Is training of concerned personnel necessary
11.4 Calibration required
11.5 Validation / Revalidation required
11.6 Qualification / Re-Qualification required
Other comments if any:
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
QA Reviewed by : __________________ Date: _________________
III. CHANGE APPROVAL
12.0 Approval signature from other departments (To be identified by QA):
(Tick which ever is applicable)

Form No. : QA-004-00 Effective date :

Reference SOP No.: Current version of 20-002 Next review due :

Prepared by:___________ Reviewed by : _________ Reviewed by: _________ Approved by: _________
Date : ___________ Date : __________ Date : ___________ Date : __________
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HONOUR LAB LIMITED (UNIT-V)
CHANGE REQUEST FORM
CR No.:________________________________
Approval
Department Status Comments Sign / Date
required
Approved /
Production Yes / No
Not approved
Approved /
Quality Control Yes / No
Not approved
Approved /
Warehouse Yes / No
Not approved
Approved /
R&D Yes / No
Not approved
Approved /
Engineering Yes / No
Not approved
Approved /
EH&S Yes / No
Not approved
Others_________ Approved /
Yes / No
(Specify) Not approved
Approved /
Plant Head Yes / No
Not approved
Approved /
Quality Assurance Yes / No
Not approved
1. Is the customer notification
required - Yes No
2. Regulatory status verification
required - Yes No
3. Is the DMF affected and needs
update - Yes No
Regulatory Approved /
Yes / No Comments:
Affairs Not approved

IV. CHANGE IMPLEMENTATION REVIEW (Change review after implementation by requester

department)
13.0 Change Implemented on: ______________________ YES NO
13.1 After initiation, is the change implemented within 30 days?

Form No. : QA-004-00 Effective date :

Reference SOP No.: Current version of 20-002 Next review due :

Prepared by:___________ Reviewed by : _________ Reviewed by: _________ Approved by: _________
Date : ___________ Date : __________ Date : ___________ Date : __________
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HONOUR LAB LIMITED (UNIT-V)
CHANGE REQUEST FORM
CR No.:________________________________
13.2 If No, Status and justification of extension:
____________________________________________________________________________
____________________________________________________________________________

Requester: _______________ Department Head: ______________QA Approval: ____________

Date : _______________ Date : ______________ Date : _____________

13.3 If yes, Effectiveness & summary of the results after change performed:
(Attach additional sheet if required):
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________

Requester : __________________ Date: _________________

Head of the department: __________________ Date: _________________
14.0 Approval signature from other departments (To be identified by QA) (Put √ mark).
Approval
Department Status Comments Sign / Date
required
Approved /
Production Yes / No
Not approved
Approved /
Quality Control Yes / No
Not approved
Approved /
Warehouse Yes / No
Not approved
Approved /
R&D Yes / No
Not approved
Approved /
Engineering Yes / No
Not approved
Approved /
EH&S Yes / No
Not approved
Others_________ Approved /
Yes / No
(Specify) Not approved
Approved /
Plant Head Yes / No
Not approved
15.0 Quality Assurance Review:
Change review status (Put √ mark)
Form No. : QA-004-00 Effective date :
Reference SOP No.: Current version of 20-002 Next review due :

Prepared by:___________ Reviewed by : _________ Reviewed by: _________ Approved by: _________
Date : ___________ Date : __________ Date : ___________ Date : __________
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HONOUR LAB LIMITED (UNIT-V)
CHANGE REQUEST FORM
CR No.:________________________________
Process YES NO NA
15.1 Manufacturing data
15.2 Analysis data
15.3 Stability data
15.4 Equipment malfunction history
15.5 Calibrations status
15.6 Validation / Revalidation status
15.7 Qualification / Re-Qualification status
General YES NO NA
15.8 Training documents
15.9 Related documents updated
15.10 The change review by relevant department is satisfactory
Comments if any:
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________

QA Signature : __________________ Date: _________________

16.0 Regulatory Affairs Review :

Approval
Department Status Comments Sign / Date
required
1. Is the customer notified
- Yes No NA
2. Is the affected DMF updated
Approved / - Yes No NA
Regulatory Affairs Yes / No
Not approved Comments:

Form No. : QA-004-00 Effective date :

Reference SOP No.: Current version of 20-002 Next review due :

Prepared by:___________ Reviewed by : _________ Reviewed by: _________ Approved by: _________
Date : ___________ Date : __________ Date : ___________ Date : __________
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HONOUR LAB LIMITED (UNIT-V)
CHANGE REQUEST FORM
CR No.:________________________________

V. FINAL REVIEW AND CLOSURE

QA review & comments:
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________

QA Signature : __________________ Date: _________________

QA Head : __________________ Date: _________________

Form No. : QA-004-00 Effective date :

Reference SOP No.: Current version of 20-002 Next review due :

Prepared by:___________ Reviewed by : _________ Reviewed by: _________ Approved by: _________
Date : ___________ Date : __________ Date : ___________ Date : __________
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