023-Change Control (AutoRecovered) B

HMA MEDICAL LTD Page 1 of 7
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE
Title: Change Control
Department: Quality Assurance Issued Date: 7th August, 2023
Mandatory Review Date: 6th August, 2025 Effective Date: 8th August, 2023
No.: HMA/QAD/SOP023-03 Supersede: HMA/QC/SOP001-02
1.0 OBJECTIVE:
The purpose of this SOP is to lay down a procedure to define the mechanism for the initiate,
review and authorization of changes in all master documents, master system and their control.
2.0 SCOPE:
This procedure applies to handle the change control at the manufacturing facility.
3.0 RESPONSIBILITY:
Doing: – Quality Assurance Executive (Prepare the SOP and follow-up the SOP accordingly)
Checking: Quality Assurance Manager & Regulatory affairs -Provide the support to the
Implementation of SOP and maintained the records.
4.0 ABBREVIATIONS:
SOP Standard Operating Procedure QAD Quality Assurance Department
QC Quality Control CCF Change Control Form
NA Not Applicable NO Number
R$D Research and Development RA Regulatory Affairs
5.0 DEFINITIONS:
Not Applicable.
6.0 PROCEDURE:
Function Name Designation Signature Date
Compiled by Quality Assurance Executive
Reviewed by Quality Control Manager
Approved by Quality Assurance Manager
Authorised by General Manager


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.
6.1. Initial of change (s)
6.1.1. No “authorized” document can be changes without being duly authorized in accordance with
this procedure.
6.1.2. Each document change request must be initiated by completion of a change control form
(CCF)
as per Annexure –I.
6.1.3. The Asst. manager of Quality assurance & Regulatory affairs has the responsibility for
controlling and tracking the CCF.
6.1.4. The user department shall initiate the changes required by filling and submitted CCF from
along with supporting documents to QA department.
6.1.5. Changes to be established must have sound/ scientific justification.
6.1.6. The impact of any proposed change on the quality of the final product must be fully evaluated
and documented.
6.1.7. Quality assurance will assign a CCF No. for the documentation.
6.1.8. CCF numbering system: It contains combination of 8 digit and letters. e.g. XYZ/CC-XXXX
Where XYZ - stands for company initial
CC - Change control
XXXX – 1st X stands for last digit of current year & next 3X’s stands for serial No.


XYZ/CC - 18001 will be CCF No. for 1st change control of the year 2018.
6.2. Management review and approval
6.2.1. Circulate the CCF together with supporting documentation, to the Head – Quality assurance
& Regulatory affairs, R&D, Production, Quality control and Warehouse as appropriate
for their review and comments. Cost/ Productivity improvements must be fully justified
and counter signed by the Plant Head/ Technical Director.
6.3. Review and authorized process
6.3.1. Submit CCF documents to Quality assurance for review and authorization before
implementation.
6.3.2. The Quality Assurance & Regulatory affairs must assign a category of change to each CCF.
Category ‘A’ - No regulatory impact.
Category ‘B’ - Minor changes (Notification to the Regulatory authorities required)
Category ‘C’ - Major change/s that (Approval from the Regulatory authorities is required
before implementation.).
6.3.3. The review and authorized of a change shall include a sign by Head of Quality assurance &
Regulatory affairs, Engineering, Quality control, Production, Warehouse and
Engineering.
6.3.4. The Head of Quality assurance & Regulatory affairs 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 authorized the change (if applicable)
shall finally authorize all change control (s).


6.3.5. A duly completed change control form as per Annexure- II shall be finally signed by QA
dept.
6.3.6. CCF No will have stamping “CONTROLLED COPY” in black colour on right corner on
each page of front side.
6.3.7. Issuance and controlling record will be maintained in QA department as per Annexure-I.
6.4. Implementing a Change

6.4.1. The concerned department should specify the object of the change and the significant reasons
and circumstances of change in Annexure 1 on the change request. He should then sign
and date it.
6.4.2. The head of area affected by the change should have the opportunity risks and to suggest
necessary measures and schedules. In any case, they should be acquainted with the
planned change. This is documented in Annexure 1, page 2 on the change request.
6.4.3. The QA Personnel shall transfer the data required to identify the procedure into the change
control database.
6.4.4. The members of the CCC jointly carry out a risk analysis of the change request under
Annexure 1, classify the change under page 2 and give their decision to authorize or reject
the change application under no. 3.3. authorization may be associated with a time scale.
The applicant and his head of area are informed of the decision via a copy of the
completed change request.


6.4.5. A decision by the control committee in accordance with Annexure 1, page 2 may only be
made if all the information and documents relevant to the decision are submitted. If
necessary, the request may be returned to the applicant for completion.
6.5. Approval of change by initiating Department Head
The Head of department/designee shall review the feasibility of change with respect to
the proposal and its reason for the change, risk assessment, and supporting documents. If
the proposed change is not feasible, the head of the department/designee shall reject the
change after consulting with Head QA.
6.5.1. Any additional information/justification is required from the initiator, change control shall be
returned to the initiator (reconsideration) with comments by the head of the
department/designee for correction.
If the proposed change is feasible / found satisfactory, the head of the department/designee
of the initiating department shall enter their consent (regarding the impact on their
documents /activities/system), and approve the change, so the change control will be
forwarded to QA for next course of action.
6.5.2. The first level of evaluation of change control by QA:
6.5.2.1. QA personnel shall review the change control and attached documents for correctness.
6.5.2.2. If the change request needs further clarification or justification, shall be returned to the
initiator (reconsideration) for corrections.
6.5.2.3. If change control is acceptable, designated QA personnel shall assess the impact of the
proposed change (primary assessment) as per predefined parameters in the change control.
6.5.3. Second level evaluation of change control by Impact Assessment Team:


6.5.3.1. After completion of the primary assessment, change control shall be forwarded to the
Impact Assessment Team (IAT) for their review and comments along with responsibility.
6.5.3.2. IAT shall be decided, based on the recommendation from the initiating department head,
and impact assessment shall be done.
6.5.3.3. If required DRA shall inform the authority about the change where approval from the
regulatory authority shall be taken prior to implementation.
6.5.3.4. If the change is pertaining to contract manufacturing product, approval from the customer,
MA holder / PL / QA shall be taken and communication shall be attached to change control.
6.5.3.5. After receipt of comments from IAT, the designated QA person shall review the comments
and forward to head QA for further approval of comments.
Review by QA:
6.5.3.6. Designated QA personnel shall review the comments made in the change control by the
IAT team and evaluate all content before the approval of Head QA on change control.
6.5.3.7. QA Manager shall put their comment in change control and classify the change as
minor/major/critical.
7.0 ANNEXURES:
Annexure I- Change Control Form
Annexure II – Change Control Logbook


8.0 FREQUENCY:
As at when required
9.0 DISTRIBUTION LIST:

Master Copy: Quality Assurance Manager
Control Copy: Quality Control
10.0 REFERENCE DOCUMENT:

Not Applicable
11.0 REVISION HISTORY:
Revision No. Effective Date Reason for Revision

01 November, 2019 Expired
02 November, 2021 Expired
03 August, 2023 Review of SOP Format

Annexure I
Ref: HMA/QAD/SOP023-03 CHANGE CONTROL FORM QA Form-026
Change Control No.
1. Proposal for Change: (To be filled by initiator)
Initiator’s Name Designation
Date Department
Tick  as applicable  Temporary change  Permanent change
Short
description of the
change
Product/
Material and Batch
No.
Type of Change  Facility  Document  Material  Formulation  Equipment  Process/Procedure
(Tick  as applicable)  Other if any _____________
Current Status:
Proposed Changes:
Reason/Justification for Change: (Provide the supporting data)
2. Assessment of the change (To be filled by Initiator)

Sr. No. Impact of Change On Yes/No Document number (if any) Remark
2.1 Facility
Modification/renewal
Design and Construction
Layout
Qualification
2.2 Document (Note: Supersede documents to be invalidated prior to issuance of the revised document)
SOP’s
Formats
Master lists
SMF
VMP
MFR
BMR
MPR
BPR
Specification/Test Protocol
Training
Stability Protocol
1.3 Material
New vendor/additional mfg. site
Item code Generation
Artwork
Approved Vendor List
Specification
Method of Analysis
2.4 Formulation
Process/Packing Validation
Cleaning validation
Hold time study
Stability
1.5 Equipment/Instrument
New/modification
Qualification (IQ, OQ, PQ)
Sr. No. Impact of Change On Yes/No Document number (if any) Remark
Equipment
Calibration
PM schedule
Cleaning Validation
1.6 Other Impact (If any)
Risk Analysis for the change :
Are additional sheets attached? Yes  No  Number of pages attached.

Initiator’s sign Date
Concurrence from
Department Head
Dept. Head sign Date
3. Review by Change Control Coordinator (QA):

Is the data provided adequate for assessment of the change Yes  No 
Is the change control complete and correct? Yes  No 
 Major (Definition: Any change in the product, production process, quality controls, equipment,
facilities, or responsible personnel that have a substantial potential to have adverse effect on the
identity, strength, quality, purity, or potency of the product as they relate to the safety or effectiveness
Category of Change
of the product).
(Tick 
as applicable)  Minor (Definition: Any Changes in the product, production process, quality controls, equipment,
facilities, or responsible personnel that have a minimal potential to have an adverse effect on the
identity, strength, quality, purity, or potency of the product as they relate to the safety or
effectiveness).
1.1 Impact assessment required from (Tick as per the requirement except initiating dept.)
Quality Control Department Yes  No  Regulatory Affairs Yes  No 
Manufacturing Department Yes  No  Formulation Research & Development Yes  No 
Packing Department Yes  No  Analytical Research & Development Yes  No 
Warehouse Department Yes  No  Packaging development Yes  No 
Engineering Department Yes  No  Information Technology Department Yes  No 
Purchase Yes  No  Marketing Yes  No 
Artwork Yes  No  Planning Yes  No 
Human Resource & Admin Yes  No  Technology transfer Yes  No 
Customer/QP approval Yes  No  Quality Assurance Yes  No 
Customer to be informed Yes  No  Corporate Quality Assurance Department Yes  No 
Other (Please specify)
Change Control
Name Sign Date
Coordinator
4. Impact assessment (To be filled by the reviewer identified in above table)

Reviewer’s Name: Dept.
 Acceptable  Not Acceptable Sign Date
Reviewer’s Name: Dept. (Any other) _____________

Regulatory Approval
Customer/QP Approval (Mandatory for all product related major change controls)
Does the change have any impact over the existing Technical Agreement? Yes  No 
Does the change have any impact over the existing Marketing Authorization? Yes  No 
Ref: HMA/QAD/SOP023-03
Reviewer’s Name Designatio
n
 Approved  Rejected Sign Date
5. Compilation of actions for Change implementation: (To be filled by change control coordinator)
Reviewer by change control coordinator prior to compilation of actions
Is impact assessment from all required dept. completed? Yes  No  NA 
Is regulatory approval available? Yes  No  NA 
Is customer approval/notification available? Yes  No  NA 
Are all comments reviewed and found appropriate? Yes  No  NA 
Sr. no. Actions Responsibility Target Completion Sign/ Date

completio date (after
n date completion)
Target completion date for complete changes 90days or based on TCD defined in above section:
Change Control Coordinator sign Date
Approval by Head: QA/QC/Authorized person Name

Is overall assessment of change control form appropriate? Yes  No  NA 
Are all action items captured for implementation? Yes  No  NA 
Approval by Head: QA/QC/Authorized person Name
6. Closure (To be completed by the initiating dept.):

All Actions completed as per section 5  Yes  No
Actions partially completed, if any (Please mention):
Reason for partial completion of actions:
Does the implementation of the change/s had any deleterious impact over the product quality  Yes  No  NA
Closure comments:
Initiator Sign Date

Department head Sign Date
Review and Closure by QA
Closed within the timeframe  Yes  No

Extension from filed-1  Yes  No  NA
Extension from filed-2  Yes  No  NA
Quality Risk assessment complete  Yes  No  NA
Change control form closed  Yes  No
Change control Coordinator Sign Date
Attachment/ List of Annexure/Attachments (Attach all supporting documents including e- Number of pages
Annexure no. mail communications)
Total No. of pages.
Annexure II
CHANGE CONROL LOGBOOK
(Ref: HMA/QAD/SOP023-03)
Date CC Existing Proposed Reason CC Effective Initiated Checked Verified

NO System Change for Approved/Rejected Date of By By by QA
Details Details Change Change

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HMA MEDICAL LTD Page 1 of 7

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

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

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

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

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

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

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

6.4. Implementing a Change

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

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

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

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

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

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

9.0 DISTRIBUTION LIST:

10.0 REFERENCE DOCUMENT:

11.0 REVISION HISTORY:

Revision No. Effective Date Reason for Revision

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

Reason/Justification for Change: (Provide the supporting data)

2. Assessment of the change (To be filled by Initiator)

Risk Analysis for the change :

Are additional sheets attached? Yes  No  Number of pages attached.

Dept. Head sign Date

3. Review by Change Control Coordinator (QA):

4. Impact assessment (To be filled by the reviewer identified in above table)

 Acceptable  Not Acceptable Sign Date

Reviewer’s Name: Dept. (Any other) _____________

 Acceptable  Not Acceptable Sign Date

 Acceptable  Not Acceptable Sign Date

Sr. no. Actions Responsibility Target Completion Sign/ Date

Change Control Coordinator sign Date