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No.

: QAS-NS/FOR/CP/007
Revision : 05
CHANGE CONTROL FORM Effective Date : 09 Februari 2015
Page : 1 of 4

Change Control Number: Change Control issued Date: 02 April 2015


CC/CP/VAL/15/04/01
Classification of Change : Level 1 Level 2

Initiator Name Giva Olviana Yudhista


Department Validation
Product/Process/Document Validation Master Plan, Process Validation
/Testing/System/Equipment Affected VAL-PV/VMP/CP/001 Rev.09
Change Type Material/ Product Equipment
Process/ Procedure/
Building
Method
Analytical Test Method Document
Specification System
Stability
Others :
Utilities
Validation Master Plan, Process Validation
VAL-PV/VMP/CP/001 Rev.09
Previous/Current Status
- Leader for Validation Department was called Site
Validation Coordinator.
Validation Master Plan, Process Validation
VAL-PV/VMP/CP/001 Rev.10
Description of Change
- Change the title for Site Validation Coordinator to
be Validation Manager
Reason for Change - Appropriate with the latest condition
Business Justification To comply with the cGMP
All market supplied by PT. Caprifarmindo
Markets Affected
Laboratories
Target date of implementation 21 April 2015
Risk assessment to evaluate the risks that may arise due to the changes
Risk Identified If yes, action to be taken to reduce the risk
*)
Personnel : Yes / No N/A
*)
Equipment : Yes / No N/A
*)
System/Process : Yes / No N/A
*)
Facility/Utility : Yes / No N/A
*)
Environment : Yes / No N/A
Starting Material : Yes / No*) N/A
*)
Product Quality : Yes / No N/A
Others :
Name : (Sign and date)
Change Control Contact
Changes Proposed by
Name : (Sign and date)
Change Control Owner
*)
Cross out unnecessary

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No. : QAS-NS/FOR/CP/007
Revision : 05
CHANGE CONTROL FORM Effective Date : 09 Februari 2015
Page : 2 of 4

SECTION A: Internal Review

Internal Assessment Panel Position Status


Date
Owner Impacted * Not Impacted Comment
Approved ** Sign
Function Name Department Department
By (√)
(√) (√) (√)
Owner Arif Agus
Setiawan √

QC Manager Rahmi Budi A.

Solid Novita Purwanti


Production
Manager
Liquid & R. Dery
Semisolid Pramudya
Production
Manager
PPIC Manager Purwantoro

RnD Manager Herwanto

Engineering Ruchimat Y.
Manager
Personnel Edi Mulyana
Manager
Plant Khairudin
Manager
Third Party
Manager
QA Manager Lutfi Febrina

Head of Sumardi
Quality
Date of Internal Panel Review

Decision and Recommendation


(by Approver)

*) Review just done by impacted department


**) Approval of Level I by QA Manager, Level II by Head of Quality

SECTION B: Checklist Related Document Required for Implementation of Change.


\\Cimareme\Release\Capri\QAS\NS\SOP\QAS.NS.SOP.CP.012 - Change Management- .doc
No. : QAS-NS/FOR/CP/007
Revision : 05
CHANGE CONTROL FORM Effective Date : 09 Februari 2015
Page : 3 of 4

Just filled in by impacted document as per section A.

Impacted Document Closing


Related Actual Not
No. Document Attached
Department Title completion attached
no. (√)
Date Status (√)
1. Quality
Assurance
2. Validation VALIDATION MASTER PLAN VAL-
(Process Validation) PV/VMP
/CP/001,
Revision.
10

3. QC-IPC

4. Production

5. PPIC

6. RnD

7. Engineering

8. Personnel

9. Third Party

Approved by, Approved by,

QA Manager QA Manager
Note :
Typical document affected e.g 1. Batch Manufacturing Record; 2. Finished product specification; 3. Starting Material Specification;
4. Analytical Method Validation; 5. Process Validation; 6. Stability Study; 7.Qualification; 8. SOP ; Others

SECTION C: Regulatory Status of Proposed Change

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No. : QAS-NS/FOR/CP/007
Revision : 05
CHANGE CONTROL FORM Effective Date : 09 Februari 2015
Page : 4 of 4

Changes can be implemented immediately without waiting for permission from the BPOM/
Indonesian National Agency of Drug and Food Control, because:
Notification will be submitted along with the changes in the relevant documents by the
Department of Registration afterward
Not required notification
Changes require prior permission BPOM/ Indonesian National Agency of Drug and Food Control
Changes can be implemented before approval from BPOM/ Indonesian National Agency of Drug
and Food Control is received.
Notification of changes will be reported by:

(Name, Sign and Date)


The changes were approved by the BPOM/ Indonesian National Agency of Drug and Food Control
Date:
Necessary to inform or approval International Regulatory
Yes
No
The changes were approved by International Regulatory
Date:

Regulatory Manager :

SECTION D : Approval for Implementation of the Change

All requirements for the implementation of this change have now been met

Change Control Owner: Date:

The change may now be implemented

Designated QA Approver: Date:

Conclusion
That the undersigned hereby declare that all aspects of changes met on the procedures and stated that all
have completed the necessary paperwork is prepared and all affected systems the impact of the changes
has been adjusted and it meets the criteria applicable.
The change has been now implemented

Reviewed by QA Pharmacist, Designated QA Manager Approver:

Name : Name :
(Date and Sign) (Date and Sign)
Keterangan:
and : Proposal
and : Closing

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