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STANDARD OPERATING PROCEDURE
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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 1 of 26

1.0 OBJECTIVE:
To lay down a Procedure to define the Standard Operating Procedure for Change Control Management.

2.0 SCOPE:
2.1 The scope of the SOP is applicable for change control management at ……………. related to
following areas but shall not be limited to following:
2.1.1 Change in the manufacturing or analytical equipment/instrument.
2.1.2 Addition/discontinuation/modification/transfer of any equipment.
2.1.3 Change in qualification, validation or revalidation approach, formats/protocol/reports.
2.1.4 Change in formulation/manufacturing process/process parameters/key steps.
2.1.5 Changes in the facility/utilities/design and the layout (including man material movement,
equipment, duct, loop routing, filter supply lines etc.)
2.1.6 Pharmacopoeias Change
2.1.7 Change in specifications (raw material/packing material/in process intermediates/
finished product /stability)
2.1.8 Analytical methods/Analytical Method approach.
2.1.9 Product shelf life /storage conditions/label claim.
2.1.10 Changes in the documents (SOPs, Site Master File, Validation Master Plan, Cleaning
Validation Master Plan and other documents)
2.1.11 Change in source of raw material (API, Key starting material, excipient)/primary
packing material.
2.2 Change in Batch Size
2.2.1 Change in Container closure system.
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TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
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2.2.2 Change in artworks/Pack configuration /Pack size/Pack presentation

2.2.3 Changes related to Computer system, BOM, Item Codes.
2.2.4 Batch records (Format, Instructions, parameters, reconciliation, limits /ranges)

3.0 RESPONSIBILITY:
3.1 Officer/Executive-QA
3.1.1 Officer/Executive QA shall be responsible for issuance of change control form to the
concerned department on receiving Request Form for Issuance of Documents.
3.1.2 To log the change control form and assign tracking number to it.
3.1.3 To verify the documents related to change control has been completed after
implementation of the proposed change.
3.2 Initiator : A responsible person in the department or the function may suggest the Change(s)
and shall
3.2.1 Initiate the change proposal in the prescribed format.
3.2.2 Follow up for evaluation and decision on the proposed change.
3.2.3 Complete the necessary activity /document(s) as identified before and after approval of
change for implementation.
3.2.4 To implement the change, if approved and monitor its progress.
3.2.5 Furnish the required information /data after implementation of change to functional Head
and QA for impact assessment and evaluation post implementation.
3.3 Head of the Department
3.3.1 To review the Change proposal submitted in the prescribed format and evaluate if the
reason/ justification given in support of the change(s) proposed are appropriate and

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TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
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justified.
3.3.2 To guide initiator for evaluation and impact assessment of the proposed change.
3.3.3 To discuss the proposal with concerned stakeholder (if applicable). Attach feasibility
report if necessary with the change proposal.
3.3.4 To recommend the proposed change after review and forward the same to QA.
3.3.5 To ensure the implementation of the change after approval from QA.
3.3.6 To review the post implementation data and forward to QA for closure of the change
proposed.
3.3.7 In case the proposed change(s) does not serve the purpose, ensure return to the original
practice/position.
3.4 Manager QA or his/her Designee
3.4.1 To review the change proposal.
3.4.2 To verify if all the necessary attachments are attached to support the proposal.
3.4.3 To evaluate the proposed change and its impact on safety, purity, efficacy, quality of the
product, cGMP, documentation and training requirements.
3.4.4 Identify the actions required as part of impact assessment as consequence to the proposal
made.
3.4.5 Identify the departments from where evaluation of change is required and arrange to
forward the proposal to the concerned department for their evaluation/comments and
acceptance.
3.4.6 To decide if the change proposed requires the review /comments, approval from the RA,
or any other corporate functions as applicable.
3.4.7 To communicate the decision on the approval /rejection of the proposed change to the
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TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
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initiator and head of the department.

3.4.8 To monitor the implementation of the approved change if the proposed change is
approved by Head QA.
3.4.9 To verify that the activities as identified during evaluation and impact assessment has
been accomplished and complete.
3.4.10 To review post implementation information/data and ensure for closure of Change
Control after verification of completion of actions as identified during the review and
approval.
3.5 Head QA or his/her Designee:
3.5.1 To evaluate the proposed change and to approve or reject by considering the evaluation
reports and decision/comments of other persons (as applicable) who have evaluated
the proposal.
3.5.2 To classify the change based on the evaluation as Critical, Major, Minor.
3.5.3 To review the post implementation data and recommend whether to regularize the
proposed change or to go back to the original procedure/practice or advise for generation
of additional data.
3.5.4 Periodic review of Change Control status at site.
3.6 Other departments /functions /personnel (Production, HR, Warehouse, Engineering,
Marketing, Quality Control as applicable) identified to execute the change shall be
responsible to:
3.6.1 Evaluate the proposed change and comment for acceptance or disagreement /rejection.
3.6.2 Identify any additional activity as applicable.
3.6.3 Complete necessary documentation, generate data or provide justification, as required.
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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 5 of 26

3.7 Regulatory Affairs:

3.7.1 Evaluate the change proposal for any Regulatory implications, as per the filing or
Registration profile and /or commitment made to the agency through Annual updates,
variation application, technical agreement or any other form of communication.
3.8 Notification to Customer:
3.8.1 For any proposed change it is necessary to confirm that, the proposed change will not
affect the product quality or contravene the statutory requirements. If it is require to
inform to the concern customer or to the Regulatory Agency of the concern country, it is
necessary to first get approval from the customer or Regulatory Agency of the concern
country through scan copy / hard copy of Change Control. Signed scan copy shall be
attached with change control than only proposed change shall be implemented.
4.0 ACCOUNTABILITY:
Head QA: Approval of the Change Control and ensure compliance of change management as per
this SOP.
5.0 DEFINITIONS:
5.1 Change: Any addition, deletion of or modification to a system, process, materials, products or
procedure.
Changes can be categorized as follows
• Minor
• Major
• Critical
5.2 Minor change: A change that unlikely to have detectable impact upon the identity, quality,

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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
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purity, strength, stability, safety and efficacy or physical characteristic of the product.
5.3 Major Change: A change that may have an impact upon the identity, quality, purity, strength,
stability, safety and efficacy or physical characteristic of the product.
5.4 Critical Change: A change that has a significant impact on quality and/or safety of the final
product.

6.0 PROCEDURE:
6.1 Request for Change Control Form
6.1.1 The change initiator from Concerned Department shall first raise request for change
control form from QA through ‘Request Form for Issuance of Documents’.
6.2 Logging of the Change Control Proposal:
6.2.1 Officer/Executive-QA shall assign a tracking number to the Change Control Form after
Issuance. The tracking numbers to be assigned sequentially based on the order in which
the change control is issued to concerned department, as mentioned below.
CC No. - CC/YY/NNN
Where,
CC – stands for Change Control
/ – separator
YY – stands for last digit of the year (i.e. 17 stands for 2017, 18 stands for 2018.
/ – separator
NNN – stands for the continuous serial number of the Change Control raised in the
respective year (i.e. 001, 002, 003,………….)

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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 7 of 26

6.3 Proposal for Change:

6.3.1 The proposal for change from the existing standard procedures/practices and
documentation , GMP updation shall be initiated by the initiator, reviewed by Head of
the Department and shall be forwarded to Head QA or designee for evaluation based on
the justification and supporting data provided.
6.3.2 The initiator shall fill in details of the existing system, proposed changes and justification
for the changes and shall attach the supporting data /document as required.
6.3.3 The initiator shall forward the Change Control form to Department Head for his review
and comments.
6.3.4 If the Department Head Approves the Change Control, forward the Change Control form
to QA department for review of the proposal and acceptance /rejection of the same.
6.3.5 For Flow chart of change control procedure refer to Annexure-V.
6.4 Review of the Proposed Change by QA department:
6.4.1 Manager QA or his /her designee shall review the Change proposal and the annexures /
supporting data provided along with the Change Control and impact assessment of the
change proposal for its adequacy.
6.5 Evaluation and Impact Assessment by QA Department:
6.5.1 Manager QA shall assess the impact of the Change proposal on
6.4.1.1 Product Quality and Stability
6.4.1.2 Existing cGMP system
6.4.1.3 ERP based system
6.4.1.4 Process / Quality Parameter
6.4.1.5 Manufacturing process instruction, parameters, Batch Record etc.
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SOP No. Revision No.
Effective Date Supersedes No.
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6.4.1.6 Validations /Qualifications

6.4.1.7 Analytical procedures, specification, Method Validation.
6.4.1.8 Source of the material /Vendor
6.4.1.9 Microbiological aspects
6.4.1.10 Container Closure system /Packaging
6.4.1.11 Calibration /Preventive Maintenance
6.4.1.12 Technology Transfer
6.6 Impact on the documents as listed shall be done but shall not be limited to:
6.6.1 MFR/Batch Records
6.6.2 SOPs
6.6.3 Bill of Material (Raw material and Packing material).
6.6.4 Raw Material, Packing Material , Semi Finished , Finished Product Specification/GTP
/STP/TDS
6.6.5 Site Master File/Validation Master Plan/Cleaning Master Plan/ Analytical Method
Validation
6.6.6 Validation Reports/Format
6.6.7 Stability Program/Protocol/Stability Specification
6.6.8 Drawing(s), layouts
6.6.9 Technical Agreements
6.6.10 Logbooks/Records/format
During review Manager QA shall request any further information /data supporting the
proposed change from the initiator if required.

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6.7 Comments from Impacted Departments:

6.7.1 Based on the nature of the change, Manager QA shall identify the department whose
evaluation is required for the proposed change. This shall include but shall not be
limited to department such as Production, Warehouse, Quality Control, Quality
Assurance, Engineering, Human Resource, Purchase and Planning, RA, Marketing or
any other as applicable.
6.7.2 Initiator shall seek evaluation of the department /personnel as recommended by QA.
6.8 Risk Assessment of proposed change(s):
6.8.1 Manager QA shall review the change proposal after impact assessment. If the change
has a direct impact on product quality and safety then risk assessment shall be
performed as per SOP to mitigate the risk.
6.8.2 Concerned department and impacted department associated with the proposed
change(s) shall write their change action plan along with signature and date. Each
department involved in change action plan shall mention the target completion date for
the activity to be performed and forward the change control to Head QA.
6.9 Guidance for categorization to Head QA:
6.9.1 Critical: If the proposed change has impact on the product submitted/and or approved
by a regulatory agency or if it has direct impact on product quality which includes:
6.9.1.1 Change related to API source
6.9.1.2 Change related to critical process parameters
6.9.1.3 Change related to primary packing material
6.9.1.4 Change related to specification, analytical method
6.9.1.5 Major modification in equipment and facility design
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6.9.1.6 Change in environmental conditions that affect the product quality and
stability
6.9.1.7 Change in product usage directions
6.9.1.8 Change related to basic ERP / other computer software system in use.
Note: Risk Assessment shall be performed for Change Proposal which is categorized
as Critical as per SOP.
6.9.2 Major: If the proposed change may have impact on the product quality.
6.9.2.1 Modification in the facility, utility systems, addition or replacement of
Equipment with same principle of operation.
6.9.2.2 Changes related to the non-critical process parameters/operating steps/
instructions.
6.9.2.3 Changes in the stability program.
6.9.2.4 Changes in secondary packing material.
6.9.2.5 Major modifications for enhancement of GMP/GLP at the site for
improvement in product Quality.
6.9.2.6 Source of major excipient and updation in its specifications.
6.9.2.7 Change in cleaning procedure(s).
6.9.2.8 Increase in batch size without any change in the ingredients and with
Proportional change in quality of ingredients as per proposed batch size.
6.9.2.9 Change in artworks of primary/ secondary packing materials /color
combination/label claim/label design.
6.9.2.10 Change in registration profile for products already registered with agency.
6.9.2.11 Major changes related to master data in ERP.
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6.9.2.12 Modification/ updated related to ERP/ computer system (software and

hardware).
6.9.2.13 Changes related to Pharmacopoeia updation.
6.9.2.14 Changes related to manufacturing site of the vendor for API, key excipients
and primary packing materials.
6.9.2.15 Other changes which may have impact on the product quality.
6.9.3 Minor: If the propose change is unlikely to have any detectable impact on the quality
of the product.
6.9.3.1 Changes in the recording formats/log books.
6.9.3.2 Changes in the SOPs and other documents.
6.9.3.3 Changes related to frequency and recording.
6.9.3.4 Minor changes done for GMP enhancements for compliance.
6.9.3.5 Information updation in SMF, VMP etc.
6.9.3.6 Minor changes in the SOP.
6.9.3.7 Editorial changes in the documents.
6.9.4 Head QA shall categorize the change(s) as Minor, Major, Critical on the basis of
impact assessment performed.
6.10 Approval of Change:
6.10.1 Head QA Approval:
Based on the comments and evaluation done by Head QA and other department (as
Applicable) Head QA or his/her designee shall Approve/Reject the change proposal.
6.10.2 If the change proposal is rejected by Head QA it shall be informed to Concerned
Department Head.
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6.10.3 In case of disagreements on decision for recommending the change among identified
evaluators, the final decision shall be taken by Head QA/Designee with justification.
6.11 Implementation of the Approved Change:
6.11.1 On receipt of the information regarding approval of the proposed change, initiator or
other department as identified shall carry out the activity /actions /document revision
/new document preparation as recommended for the implementation of the proposed
change.
6.11.2 On completion of the activity the implementer shall inform to the QA Department and
shall submit the necessary data/information as required.
6.12 Post Implementation review by QA Department:
6.12.1 Head QA shall verify the data/ information as submitted and if found satisfactory shall
authorize for regularization of the change. In case, the data /information is not
satisfactory Head QA shall advise to return to the original procedure/practice and
discontinuation of the approved change.
6.13 Closure of the Change Control:
6.13.1 After the post implementation evaluation of change implemented, Manager QA
/Designee at site shall close the change control form after verifying:
6.13.1.1 The result and supporting data are satisfactory.
6.13.1.2 Completion of the required activities/documents as identified during the
evaluation and approval of change.
6.13.1.3 The proposed change meets its objective based on impact assessment.
6.13.1.4 All the documents related Change Control shall be closed within 30 days from
the date of approval of Change Proposal.
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6.13.1.5 Change Control related to stability study shall be closed within 6 months from
the date of approval.
6.13.1.6 Facility related Change Control shall be closed within 6 months from the date
of Change Control Approval.
6.14 Interim Closure:
6.14.1 A change control may be closed by QA in the interim, if all activities are completed
but the final implementation /regularization is pending for approval from agency (e.g.
pre-approval from FDA, variation application or country specific MOH) or generation
of the stability data.
6.14.2 Interim closure may be done by QA, justifying the reason by using Interim Closure of
the Change Control (Format No.: F04).
6.14.3 The disposition of any product placed on “QA HOLD” as a result a Change Control
will be evaluated by the Quality Assurance upon completion of the Change Control
and any applicable testing.
6.15 Extension of the Change Control:
6.15.1 All the actions / activity pertaining to the implementation of the approved Change
Control shall be completed within 30 days of the approval of Change Proposal and
facility & stability related Change Control shall be closed within 6 months from date
of Approval. However if the implementation of the activities is not completed within
defined time frame, extension form (Format No.: F03) may be requested, which may
be approved by Head QA if justified.
6.16 Review of the Change Control shall be carried out quarterly & trend shall be prepared by QA
Department according to SOP.
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7.0 ABBREVIATIONS:
BMR : Batch Manufacturing Record
BPR : Batch Packing Record
cGMP : Current Good Manufacturing Practices
CC : Change Control
GLP : Good Laboratory Practices
HVAC : Heating Ventilation and Air Conditioning
WHO : World Health Organization
TRS : Technical Report Series
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
API : Active Pharmaceutical Ingredient
BOM : Bill of Material
RA : Regulatory Affairs
MFR : Master Formula Record
GTP : General Test Procedure
STP : Standard Test Procedure
ERP : Enterprise Resource Planning
SMF : Site Master File
VMP : Validation Master Plan

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8.0 ANNEXURES:
ANNEXURE No. TITLE OF ANNEXURE FORMAT No.
Annexure-I Change Control Form SOP/QA/008/F01-02

Annexure-II Change Control Issue log book SOP/QA/008/F02-02

Annexure-III Extension of Change Control form SOP/QA/008/F03-00
Annexure-IV Interim Closure of the Change Control SOP/QA/008/F04-01

Annexure-V Change Control Flowchart SOP/QA/008/F05-00

9.0 DISTRIBUTION:
• Master Copy Quality Assurance Department
• Controlled Copy No. 01 Quality Assurance Department
• Controlled Copy No. 02 Quality Control Department
• Controlled Copy No. 03 Production Department
• Controlled Copy No. 04 Human Resource Department (HR)
• Controlled Copy No. 05 Engineering Department
• Controlled Copy No. 06 Warehouse Department (Store)
• Controlled Copy No. 07 Information Technology Department.

10.0 REFERENCES:
IN HOUSE

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11.0 REVISION HISTORY:

Revision Change Control Details of Changes Reason of Effective Done
No. No. Changes Date By

00 Not Not Applicable New SOP

Applicable

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ANNEXURE-I
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QUALITY ASSURANCE
CHANGE CONTROL FORM

Change Control No. : Name of Initiator :

Department
Date of Initiation Initiator Name
: :

A. PROPOSAL FOR CHANGE

Change related to: SOP/Document/System/Process/Equipment/Facility/Material/Any other
Existing System:

Proposed Change(s): (If require attach separate sheet)

Justification for Change(s): (If require attach separate sheet)

Initiator
Sign & Date:

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Review & Approval by Concerned Department Head:

Comments:

Sign & Date:

Assessment by Quality Assurance Department for Impact of the Proposed Change (tick mark ( ) for
Applicable and (X) for Not Applicable)
Document Details/Activity Name of Document/Activity Existing Document
recommended for review Number (If Applicable)
SOP(s)

BMR

BPR

MFR

Specification(s)

STP(s)

GTP(s)

Process Validation

Cleaning Validation

Hold Time Study

AMV(s)
Artwork(s)
Stability

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Equipment Qualification
Calibration
Vendor
License
SMF
VMP
Layouts/Drawings
ERP based system
Facility
Area Qualification
Technology Transfer
Other(s)

Comments from Impacted Department tick mark ( ) by QA and (X) for Not Applicable
Department Name Name of Comments Sign and Date
Reviewer
Quality Assurance

Quality Control

Production

Engineering

Human Resource

Warehouse
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PPIC

Regulatory Affairs

Concerned Customer/
Regulatory Agency

Any Other

Impact Assessment of the proposed change(s):

Reviewed by Manager QA
(Sign and Date):
Risk Assessment: Required Not Required
If Required perform Risk Assessment as per SOP No. SOP/QA/024
Doc. No.:
Change Action Plan (To be completed by impacted Departments)
S. No. Activity to be performed Responsible Sign and Date Target
Department Completion
Date

* Attach separate sheet if required

Category of Change: Minor/Major/Critical

Head QA
(Sign and Date):
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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 21 of 26

B. CHANGE CONTROL APPROVAL/REJECTION

Remarks:

Head QA
(Sign and Date):
C. POST IMPLEMENTATION EVALUATION OF THE CHANGE
Details of documents/activity to be reviewed Revised Document No. Date of Responsible
post implementation Implementation Department

Verified by Quality Assurance:

Remarks:

Head QA
(Sign and Date)
Recommended for the Regularization of the Proposed Change: Yes/No

D. CLOSURE OF THE CHANGE CONTROL

Date of Closure:

Quality Assurance
(Sign and Date):
FORMAT No. …………… Page X of Y

Prepared By Checked By Approved By

---
Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ……………

 WWW.PHARMASCHOLARS.IN
STANDARD OPERATING PROCEDURE
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Department: Quality Assurance
TITLE : CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 22 of 26

ANNEXURE –II
WWW.PHARMASCHOLARS.IN
QUALITY ASSURANCE

CHANGE CONTROL LOG BOOK

CHANGE CONTROL LOG BOOK

C.C.
Logged in C.C. Closed By
Originating Date of C.C.
C.C. No. By QA Description of change Category Approved/ QA Remarks
Department Initiation Closed On
Sign & Not Approved Sign/Date
Date

FORMAT No………….. Page X of Y

Prepared By Checked By Approved By

---
Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No. SOP/QA/001/F01-00

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TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 23 of 26

ANNEXURE-III
WWW.PHARMASCHOLARS.IN
QUALITY ASSURANCE
EXTENSION OF CHANGE CONTROL FORM
CHANGE CONTROL LOG BOOK
To Quality Assurance Department
From Department
Change Control No
Details of the Pending Activity :

Justification for Extension :

To be Extended Up to
Initiator
Sign/Date
Head of the Department
Sign /Date
Approval by Head QA
Sign /Date

Closing Date of the Change Control

QA Department :
Sign /Date

FORMAT No. …………………… Page X of Y

Prepared By Checked By Approved By

---
Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ……………

 WWW.PHARMASCHOLARS.IN
STANDARD OPERATING PROCEDURE
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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 24 of 26

ANNEXURE-IV
WWW.PHARMASCHOLARS.IN
QUALITY ASSURANCE
INTERIM CLOSURE OF THE CHANGE CONTROL

CHANGE CONTROL FORM NO:_____________________________

DATE OF INITIATION: _____________________________________
INITIATING DEPARTMENT: ________________________________
INITIATED BY: ____________________________________________
JUSTIFICATION/REASON FOR CLOSURE:
___________________________________________________________________________________________________________
___________________________________________________________________________________________________________
___________________________________________________________________________________________________________
___________________________________________________________________________________________________________
___________________________________________________________________________________________________________
___________________________________________________________________________________________________________
_____________________________________________________________________

Approved By:
Head QA
Sign & Date:

FORMAT No. …………………….. Page X of Y

Prepared By Checked By Approved By

---
Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ……………

 WWW.PHARMASCHOLARS.IN
STANDARD OPERATING PROCEDURE
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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 25 of 26

ANNEXURE-V
WWW.PHARMASCHOLARS.IN
QUALITY ASSURANCE
CHANGE CONTROL FLOWCHART

Request for Issuance of change control

form from Initiator Department

Issuance of Change Control Form &

assigning tracking number to it by QA

Change Initiator fills the details of change

proposal in Change Control Form

Justification for Change (s) by Initiator &

forwarded to Concerned Department Head

Review & Approval of Change Proposal

by Concerned Department Head

Change Control forwarded

to QA Department

Assessment by QA Department for impact of

the proposed change on document/activity

Initiator seek evaluation of department as

recommended by QA

Prepared By Checked By Approved By

---
Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ……………

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STANDARD OPERATING PROCEDURE
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Department: Quality Assurance
TITLE: CHANGE CONTROL MANAGEMENT
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 26 of 26

Impact analysis & risk assessment (if required) of

the proposed change reviewed by QA

Concerned Department & impacted Departments complete their change action

plan with target completion date & forwarded to Head QA for Approval

Categorization of Change
(Major, Minor, Critical) by Head QA

Approval/Rejection of Change by Head QA

Information to Concerned Department Head for implementation of

proposed change/rejection of proposed change

Post Implementation Evaluation of the Change

Verification by QA

Closure of the Change Control

Updation of change control log

FORMAT No. ………………. Page X of Y

Prepared By Checked By Approved By

---
Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ……………