Company
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Change Control Request
1- Initiation of change request
…………/ .……/…… :CCR No.: ………………………. Date
...……………………………… :Department: …………………………… initiator name
Initiator title: ………………………………….
Title of proposed change: ………………………………………………………………………………………….
Proposed starting date of change: ……………………………….
.Change type: ……. Permanent. ……. Temporary
The end date for the proposed change (If temporary): ……………
Source of change: -
Deviations Complaints Recall
Internal audits External audits BR Review
Periodic product review Trend analysis Risk Management
Management review Continual improvement Regulatory requirements
Adding/ Removing
Engineering .………………… Other
.machine or instrument
- :Scope of Change
Manufacturing or Raw or packaging
Facilities/ Utilities
control equipment material
Engineering Replacement Engineering Analytical or testing
– Equivalent/ Identical Substitute equipment
Engineering Redesign Supplier of a material Organizational change
Printed packaging
Specifications Other: ………………
component
If other, please specify: -
……………………………………………………………………………………………………….………………………..
If the changes initiated by deviation, the serial no. of deviation ……/……. /……..
Ser. Existing Proposed Change Reason of Change
Initiator signature/Date: …………………………..
Reviewer Name: …………………………………… Title: …………………………
Reviewer signature/ date: ……………………………………..
Received by (QA): ............................................................... Sig./date: ..................................
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Company
Logo
Change Control Request
2- Potential impact & Risk Assessment: (Attachment)
Use the risk management procedure using its forms, attach the record with the CCR.
Assessment Results:
The proposed change is: …… Accepted ……. Rejected.
Change classification: …….. Critical …… Major …… Minor.
Notification or regulatory Approval: (Q.A Manager)
Regulatory Approval Required Not required
Marketing Approval Required Not required
Local authority Required Not required
Validation Required Not required
Other (Specify) ………………………………………………..
3- Action Plan and its approval: (Attachment)
All Actions shall be recorded in the attached CCR Action Plan form No# XXXXX (All related departments
Head shall approve Critical and Major changes)
4- Post Change Evaluation:
………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
Initiator /Originator Sign. /Date: ............................................................
Closure date: …………………………………
Head of Quality Sign. /Date: ..............................................................
Page 2 of 2 QA.SOP004F01.01
