HMA MEDICAL LTD

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QA/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 1 of 5
Prepared By Reviewed By: Approved By: Authorized By:
Designation Asst. QA/QC QC/QA
QA/QC Officer General Manager
Manager Manager
Signature/Date

1.0 OBJECTIVE:

To lay down a procedure to define the mechanism for the initiation, review and
authorization of changes in all master documents, master system, master formulation,

master process and their control.

2.0 SCOPE:

This procedure applies to handle the change control at the manufacturing facility

3.0 RESPONSIBILITY:

3.1 Quality Control - Prepare the SOP and follow-up the SOP implementation

accordingly,

4.0 ACCOUNTABILITY: Quality Assurance/ Control manager and the initiating

department’s head

5.0 PROCEDURE:

5.1 This procedure is applicable to, but is not necessarily limited to all authorized
documents/procedure including Validation protocols, Master formula records, Batch
manufacturing records, Standard Operating procedure, Finish product specification,
Standard testing procedure, Raw material specification, Packaging material
specification.

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 2 of 5

5.2 Before change(s) is (are) initiated:

5.2.1 No “authorized” document can be changed without being duly authorized in

accordance with this procedure

5.2.2 Each document change request must be initiated by the completion of a Change
Control Form (CCF) as per Annexure –I.

5.2.3 The Quality Control/Assurance Manager or designee has the responsibility for

controlling and tracking the CCF.

5.2.4 The user department shall initiate the changes required by filling and submitting the

CCF along with supporting documents to QC/A department.

5.2.5 Changes to be established must have sound/ scientific justification.

5.2.6 The impact of any proposed change on the quality of the final product shall be fully
evaluated and documented.

5.2.7 Quality Control/Assurance shall assign a CCF No. for the documentation.

5.2.8 The CCF numbering system shall contain a combination of 15 Characters.

e.g. XYZ/AB/CC-XXXXX

 Where the first three (3) characters XYZ - stands for company’s acronym i.e
HMA
 The fourth character shall be a slash sign "/"
 The Fifth and Sixth character "AB"shall be the code for the department
undertaking the change e.g QC for Quality Control, PR for Production

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 3 of 5

 The seventh character shall be a slash sign "/"

 The eighth and ninth character shall be "CC" representing "Change Control"
 The next character ( tenth) shall be a dash sign "-"
 The last five characters (eleventh to fifteenth) xxxxx shall be in digits – 1st
and 2nd X stands for last digit of current year and the next 3X’s stands for
serial Number which is continuous

For instance, HMA/PR/CC-19001 will be CCF No. for 1st change control of the
year 2019 in the production department.

5.3 MANAGEMENT REVIEW AND APPROVAL

5.3.1 Circulate the CCF together with supporting documentation, to the Quality

Control/Assurance Manager, Production Manager and Store Officer and Accountant

as appropriate for their review and comments. Cost/ Productivity improvements must

be fully justified and counter signed by the Plant Head/ Technical Manager.

5.4 REVIEW AND AUTHORIZATION PROCESS

5.4.1 Submit CCF documents to Quality Control/Assurance for review and authorization

before implementation.

5.4.2 The Quality Control/Assurance Manager must assign a category of change to each

CCF.

5.4.3 Category ‘A’ - No regulatory impact.

Category ‘B’ - Minor changes (Notification to the Regulatory authorities required)

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 4 of 5

Category ‘C’ - Major change/s that (Approval from the Regulatory authorities is
required before implementation.)

5.4.4 The review and authorization of a change shall include a sign by Head of Quality
Control, Head of Maintenance, Head Production and Head of Warehouse

5.4.5 The Quality Control/Assurance must ensure that all information (e.g. dates of
submission /approval) relating to notification to Regulatory authorities is promptly
transmitted to the Departmental heads to authorize the change (if applicable) for
final authorization of all change control (s) to be effected.

5.4.6 A duly completed change control form as per Annexure- I shall be finally signed by
QC dept.

5.4.7 CCF No will have stamping “CONTROLLED COPY” on the right corner on each
page of front side.

5.4.8 Issuance and controlling record will be maintained in QC department as per

Annexure-II.

6.0 REVISION LOG

Revision No. Effective date Reason

01 July, 2019 Expired
02 August Expired

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 5 of 5

6.2 NA - Not Applicable

6.3 QA/QC - Quality Assurance/Control

6.4 CCF - Change Control Form

7.0 ANNEXURES

7.1 Annexure 1: Change Control Form

7.2 Annexure 2: Change Control Log Book

8.0 DISTRIBUTION

As per SOP on document Creation and Control – SOP No.HMA/QC/SOP001-01

Master copy – Quality Assurance,/Quality Control
Controlled copies- Production, Quality Control, Maintenance, warehouse/Store

ANNEXURE – I

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 6 of 5

CHANGE CONTROL FORM (CCF)- HMA/QC/SOP021-CCF/1

PART- A (To be filled by initiating Department) CCF No. ____________________

1.0 Change is requested for but not limited to followings: Tick as appropriate

1.1 Production Department

1.2 Quality control Department

1.3 Maintenance Department

1.4 Store Department

1.5 HR/Administration Department

2.0 Proposed Change:

______________________________________________________________________________
______________________________________________________________________________

3.0 Existing System:

______________________________________________________________________________
______________________________________________________________________________

4.0 Effective Document(s)

4.1 To be amended:
______________________________________________________________________________
______________________________________________________________________________

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 7 of 5

4.2 To be cancelled:
______________________________________________________________________________
________________________________________________________________________

5.0 Reason for the change:

______________________________________________________________________________
______________________________________________________________________________

6.0 Department Head’s Name: Signature: Date:

PART – B

(TO BE FILLED BY CONCERNED DEPARTMENTS)

MANAGEMENT REVIEW

8.0 Circulated to : Date _____________________

Production

Store

Quality Control

Maintenance

HR/Administration

9.0 Review of impact of CCF

Comments

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 8 of 5

Reviewed by

10.0 Cost/Productivity approval (Applicable/ Not Applicable)

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

Maintenance Manager: ______________Sign: ________________ Date: _______________

PART - C

(TO BE FILLED BY HEAD –QUALITY CONTROL)

ASSESSMENT AND AUTHORISATION OF CCF

11.0 Date of review: Feasibility of change: (Yes) (No)

12.0 Category of change (Tick as appropriate)

Category ‘A’

Category ‘B’

Category ‘C’

13.0 Date of regulatory authority approval (applicable/Not applicable) Date : ________

Comment of Quality Assurance/ Control_______________________________________

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 9 of 5

______________________________________________________________________________

14.0 QC Approval:

15.0 Final approval and authorization

Technical Manager:

Signature

Date

16.0 Date of implementation of the amend documentation: _________________________

17.0 Amended document distribution on: ______________________________________

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.
 HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
STANDARD OPERATING PROCEDURE
Title: Change Control Effective Date: August, 2021
Department: Quality Control Review Date: August, 2023
No.: HMA/QC/SOP021-02 Supersede: HMA/QC/SOP021-01 Page no.: Page 10 of 5

ANNEXURE – II

(CHANGE CONTROL LOG BOOK)- HMA/QC/SOP021-CCF/2

S.No.:

CC No.:

Issue Date of CCF:

Name of Originator:

Originating Department:

Title of Change:

Approved or Reject:

Effective Date of Change:

Verified by QC:

Sign. / Date:

Remark:

DISCLAIMER: Document Soft Copies on the Server and Hard Copies having the Official Company Stamp and
Signature of Quality Control Head are ‘Controlled and Valid’, all others are ‘Uncontrolled and Invalid’.