Change Control Form (CCF)

Ref. Doc. No.: SOP/IP/QA/004 Page 1 of 9

Part A : Change Proposal (to be completed by originator)

Scope of the Change (Site/Plant/Facility/Area): DS, 1300, SSP
Department: SC
Change Control Reference No.:
1. The Change is Related to [Put “Tick” (√)]
a. Production b. R&DA/R&DF/QA/QC/MB c. SCM/MSD/IRA
 Manufacturing process  Specification of raw material/packing material/bulk  Source/supplier of any raw material or
 Process control parameters product/finished product primary packing material
 Manufacturing facility  Addition/deletion of any raw material in the product  Design/text of any packing material
 Location  Quantity of raw material in the product  Size/shape of any packing material
 Batch size  Environmental/storage condition  Addition/deletion of any medical devices
 Shelf life  Specification of in-process/intermediate material /applicators from the final finished goods
 Method of analysis or change in sampling plans and  Introduction of a new material / product for a
 Pack Size
method local/ institutional/ export market
 Addition/ deletion of any
 Analytical step of intermediate product/materials  Packaging (primary & secondary) mode
equipment
 Addition/ deletion of any equipment  Service provider
 Product Formulation
 Analytical Equipment
 Retest interval
d. Engineering e. Warehouse f. Cleaning Procedure g. Computer System h. Others
 Any equipment  Location  Cleaning steps  Computer Inclusion of alternative
 Critical part of any  Storage  Cleaning systems source & vendor
equipment condition agents & software
 Utility systems  Transport  Cleaning
(HVAC/ Compressed Air/ condition methods
Water System/ Nitrogen
etc.)
2. Related Product/Material/Equipment/Facility: [Add additional page if required, Attachment No.: …………………………]

A. Name B. Ref./ID/Code
CRODET S40LD (MYRJ S40-PA-(RB)) 11000139

3. Description of the Change [Add additional page if required, Attachment No.: …………………………]

A. Present Status:

Currently approved source of above-mentioned material for plant 1300 (General Pharma Plant, Zirabo site) are as below
Manufacturer Name Vendor Name
CRODA CHEMICALS EUROPE LTD, ENGLAND (COWICK Croda (Code: 200067)
HALL, SNAITH GOOLE, EAST YORKSHIRE, DN14 9AA,
ENGLAND.)
BASF SE, GERMANY(CARL-BOSCH-STRASS 38, 67056 Basf South East Asia Pte Ltd.(Code: 200030)
LUDWIGSHAFEN, GERMANY)
B. Proposed Change:
It is include Croda Singapore Pte Ltd (manufacturing site: 30. Seraya Avenue, Singapore 627884. ) as alternative
source for above mentioned material and vendor will be United Pharma Industries Co Ltd. (Code: 200270).
Existing sources of CRODA CHEMICALS EUROPE LTD, ENGLAND & BASF SE, GERMANY will remain active for
the above mentioned material.

Tentative date of implementation will be:

Format No.: F01/04-IP/QA/004

 Change Control Form (CCF)
Ref. Doc. No.: SOP/IP/QA/004 Page 2 of 9

Change Control Reference No.:

Part A : Change Proposal (to be completed by originator)
4. Reason for Change: [Add additional page if required, Attachment No.: …………………………]

Compliance: To comply with the source approval procedure as per SOP for Source Approval.

N/A
Cost:

N/A
Customer:

To develop a source for the mentioned material for extension business.

Others:

Originated by: Agreed by (Dept./Section Head):

Sign & Date: Sign & Date:

Name: Md. Abdur Rahman Name: Md. Mahbubul Karim
Designation: Executive Officer, SCM Designation: General manager, SCM

Format No.: F01/04-IP/QA/004

 Change Control Form (CCF)
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Change Control Reference No.:

Part B : Change Assessment (to be completed by originator/assigned person)
1. Impact of Change:
Impact of change will be assessed based on the following guidance questionnaire (for additional assessments, please mention in others
section)-
Put “Tick” (√)
Questionnaire Yes No
uired to
intro
uce/
change
any
Is the change re approve
d
procedu
re/docu
ment?

required
to
Is registration documen generat
e/
update?

stability
of the
finished
pr
Will the change have impact on
duct or
shelf
life?

nge
have an
impact
on
specific
ation of
starting
material
Will the ch /packag
ing
material
/interme
diate/fin
ished
product
?

Will the change have an impact on storage of material/product?

Does the change have an impact on other associated material/product?
Is the change required to modify any facility or equipment?
Is revalidation (process, cleaning, and method)/requalification/recalibration necessary?
Is training required for the change?
Is the change required for revalidation/verification of any GxP critical computerized system?
Is the change required to conduct detailed separate risk assessment?
Does the change have an impact on the requirement of MAH?
Based on the above assessment put “Tick (√)” in relevant box of following table (6 P’s) or write details in ‘Others’ section and define the action
plan in Section 2 (Action Plan for the Change) of Part B.

Format No.: F01/04-IP/QA/004

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Paper Products Processes Plant Premises

 Regulatory Affairs  Starting Materials  Prod. Processes  Equipment  Buildings
 Procedures (SOP, STP etc.)  Packaging Materials  Control Parameters  Critical Parameter  Facilities
 SCA  Intermediates  Sampling Method of any Equipment  HVAC
 BMR  Finished Products  Analytical Step  Machinery  Utilities
 BPR  Specifications Reduction  Capacity  Environment
 Protocol/Report  Batch Size  Cleaning Validation  Location  Storage
 Site Master File  Stability Study  Analytical Method Condition
 QA Approved Source List  Source/Supplier  Qualification  Gases
 Other Document Instruction  SAP System-  Calibration  Cleaning Procedure
 Computerized Data  Material Master  Analysis (Chem. /Mic.) People  Layout/Design
 Quality Manual  BOM  Machine Trial  Training
 Log Book  Inspection Plan  Feasibility Study  Personal
 Ref. Standard of PM  Shelf Life  Process /System Development
Validation  Health &
 QI & ZMFRD
 Risk Assessment Safety
 Information
Sharing

Others:

Change Control Reference No.:

Part B : Change Assessment (to be completed by originator/assigned person)
2. Action Plan for the Change
2.a Action before implementation of change [Add additional page if required, Attachment No.:
 Not Applicable
…………………………]
Sl. Action Responsible Responsibl Expected Action Ref. No.* Actual Attachment
No. Person e Completio Completio No. of
(Name, Sign Department n Date n Date** Subjected
& Date) / Section Evidence
Document**
1. QI & ZMFRD will be Tabassum QA
performed in SAP to Arefin
include the source of
CRODET S40LD (MYRJ
S40-PA-(RB)) (Code:
11000139, Source:
Croda Singapore Pte
Ltd.)
2. Specification of the Jeasmin QC
previous supplier COA &
new previous supplier Akter
COA will be compared
for CRODET S40LD
(MYRJ S40-PA-(RB))
(Source new: Croda
Singapore Pte Ltd.).
3. Approved source list will Shimana QA
be updated capture the
Format No.: F01/04-IP/QA/004
 Change Control Form (CCF)
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material of CRODET Nasrin
S40LD (MYRJ S40-PA-
(RB)) (Source: Croda
Singapore Pte Ltd.).
4. All necessary documents Md. Abdur SC & QA
for of CRODET S40LD
Rahman,
(MYRJ S40-PA-(RB))
(Source: Croda Shimana
Singapore Pte Ltd.) i.e Nasrin
Specification, COfA,
Questionnaire, MOfA,
Stability study report,
TSE/BSE Certificate,
MSDS, COfC, labeling
information, Packaging
mode & Security Seal
declaration etc. will be
prepared & provided to
QA

5. Requirement of Process Md. Zahidul QC, RF

validation & stability
Islam,
study will be assessed
for inclusion for CRODET
S40LD (MYRJ S40-PA-
(RB)) (Source: Croda
Singapore Pte Ltd.).
6. SAP name of CRODET Md. Abdur SC
S40LD (MYRJ S40-PA-
Rahman
(RB)) (Source: Croda
Singapore Pte Ltd.). will
be updated to
synchronize with the
SCA & supplier COA.
7. SCA name of CRODET Md. Mehedi QC
S40LD (MYRJ S40-PA-
Faysal
(RB)) (Source: Croda
Singapore Pte Ltd.). will
be updated to SP MYRJ
S40 MBAL-PA
synchronizing with
supplier COA.
* To be filled by QA after approval of CCF ** To be filled after review of action plan by QA
Remarks (if any):

Part B : Change Assessment (to be completed by originator/assigned person)

2.b : Action after implementation of change [Add additional page if required, Attachment
 Not Applicable
No.: ……………]
Sl. Action Responsible Responsibl Expected Action Ref. No.* Actual Attachment
No. Person e Completio Completio No. of
(Name, Sign Department n Date n Date** Subjected
& Date) / Section Evidence
Document**
01 Source Qualification Shimana QA
report will be prepared Nasrin
Format No.: F01/04-IP/QA/004
 Change Control Form (CCF)
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and approved for

CRODET S40LD (MYRJ
S40-PA-(RB)) (Source:
Croda Singapore Pte
Ltd.)

* To be filled by QA after approval of CCF ** To be filled after review of action plan by QA

Remarks (If any):

Format No.: F01/04-IP/QA/004

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3. Fate of Existing Resource/Materials [Add additional page if required, Attachment No.: …………………………]  Not Applicable

4. Cost/financial Impact (will be assessed by FA) [Add additional page if required, Attachment No.:…………….…]  Not Applicable
Sign & Date:

Assessed by (Originator): Agreed by (Dept./Section Head): Reviewed by QA:

Sign & Date: Sign & Date: Sign & Date:
Name: Md. Abdur Rahman Name: Md. Mahbubul Karim Name:
Designation: Executive Officer, SCM Designation: General Manager, SCM Designation:

5. Change Control Ref. No. Allocation: (To be filled by QA)

Change Control Reference No. : Sign & Date:

6. Review Panel for CCF Approval Based on the CCF Matrix (To be assessed by QA):
Applicable Head of the departments/sections for Change Control Review: Assessed by :
 PR  PP  QC  VL  RD  RF  RA  HS  EN  RG  IRA  MS (Sign & Date)

 SC
 MB  TS  TO  WH  IT  FA  HR  AD  QA  Others
……………………….

Format No.: F01/04-IP/QA/004

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Change Control Reference No.:

Part C : Approval of Change

1. Approval of Change Control Review Panel (to be filled by respective head of department/section )
Department/ Section Assessment Remarks (if any) Sign & Date
[Put “Tick” (√)]
SC  Agreed

 Not agreed

RF  Agreed

 Not agreed

QC  Agreed

 Not agreed

QA  Agreed

 Not agreed

 Agreed

 Not agreed

 Agreed

 Not agreed

 Agreed

 Not agreed

 Agreed

 Not agreed

 Not Applicable
2. Approval of Chief Operating Officer / Executive Director (Applicable when the change
(when there is no
proposal has impact on cost/financial as assessed in Part B, Section 4)
impact on
cost/financial)

Comments (If any):

Signature:………………………………………. Date:……………………………..
3. Approval of Head of Quality Assurance
The change proposal is -  Approved /  Not Approved /  Referred for Modification

Comments (if any):

Signature:………………………………………. Date:……………………………..

Format No.: F01/04-IP/QA/004

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Change Control Reference No.:

Part D: Change Implementation, Post Change Assessment and Closing

1. Action Plan Tracking in Log (to be filled by QA)
All the actions have been captured in the action tracking log.  Yes /  No Sign & Date:

2. Change Communication (to be filled by Originator/ QA)

All responsible personnel have been communicated to complete  Yes /  No Sign & Date:
the action plan as per CCF.

3. Review of Action Plan (to be filled by Originator/ QA)

a. Action(s) related before change implementation
All actions, required before change implementation, have been completed.  Yes /  No

All supportive documents have been attached.  Yes /  No

The change is ready for implementation.  Yes /  No

Comment (if any):

Proposed by: Agreed by (Concerned Dept./Section Head): Approved by QA:

Sign & Date: Sign & Date: Sign & Date:
Name: Name: Name:
Designation: Designation: Designation:
Date of Implementation: Effective from Batch Number (if applicable):

b. Post Change Assessment  Not Applicable

All actions, required after change implementation, have been completed.  Yes /  No

All supportive documents have been attached.  Yes /  No

The change has been implemented successfully.  Yes /  No

Comment (if any):

Proposed by: Agreed by (Concerned Dept./Section Head): Approved by QA:

Sign & Date: Sign & Date: Sign & Date:
Name: Name: Name:
Designation: Designation: Designation:
4. Closing of Change Control (to be filled by QA)
The CCF is considered as closed.  Yes /  No Sign & Date:

Format No.: F01/04-IP/QA/004

Format No.: F02/01-IP/QA/004