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Change Control Process and FIND HERE

Management in Pharma Search

 Janki Singh (https://guideline-sop.com/author/janki-singh/) -  16/11/2020 ABOUT THE

AU T H O R

Standard Operating Procedure (SOP) for Procedure, Process and Management Mrs. Janki Singh is the

of Change Control (temporary change or permanent change control) in the professional pharmaceuticals
Blogger. She has already posted
pharmaceutical drug manufacturing plant.
more than #1000 articles on
varrious topics at different
Change Control Management
blogging plateforms. Contact :

1.0 Objective: [email protected]

J O I N U S FO R
To lay down the procedure to identify, initiate, evaluate, review, approve, U P DAT E S
implement, and regularize the change through a change control system.
Get all latest content delivered to
2.0 Scope – SOP for Change Control: your email a few times a month.
Updates and news about all 
This procedure covers (but not limited to) the change in- categories will send to you.
 Product Quality / Reproducibility,
Your Email GO
Facility,
Utilities and/or support systems, Accept GDPR Terms

Process Equipment, / instrument including computer data storage

C L A S S I F I C AT I O N
device/software,
Manufacturing formula, Ask Question (https://guideline-

Manufacturing/packing process & parameters, sop.com/category/ask-question/)

Process environment or manufacturing site, Calibration (https://guideline-

Standard batch size (https://www.pharmabeginers.com/batch-size- sop.com/category/calibration/)

determination/),
Checklist (https://guideline-
Specification, sop.com/category/checklist/)
Analytical methods,
Maintenance (https://guideline-
Vendor/suppliers (https://www.pharmabeginers.com/sop-for-vendor-
sop.com/category/engg/)
management/),
Microbiology (https://guideline-
Raw / packing material,
sop.com/category/microbiology/)
Artworks,
Process aids, Production (https://guideline-
sop.com/category/production/)
Holding period;
Storage and distribution Quality (https://guideline-
of product, sop.com/category/quality/)

Documentation Quality Assurance

including validation master plan, (https://guideline-

sop.com/category/quality/qa/)
Validation reports,
Qualification protocol and reports, Quality Control (https://guideline-
New material/product introduction, sop.com/category/quality/qc/)

SOP,
Quality IT (https://guideline-
Site Master File (https://www.pharmabeginers.com/site-master-file-
sop.com/category/quality-it/)
smf-preparation-sop-guideline/).
SOP's (https://guideline-
3.0 Responsibility – Change Control Process: sop.com/category/sops/)

Stores (https://guideline-
Initiating Department : The concerned persons from the originating
sop.com/category/stores/)
department shall initiate a change control.
Validation (https://guideline-

Initiating : Responsible for the review of the proposal to sop.com/category/validation/)

Department Head evaluate the impact on their department’s

FO L LO W U S
documents/system/activities. To recommend
and forward it to QA.Post effective evaluation of
change.

Impact assessment : Shall evaluate and comment on proposed

team changes.

Head QA or designee : Review of the impact of change, Classification of

change, Planning for implementation close the
change control. 
Head QA : To review the comments on proposed changes 
and approve and reject the change control.

 (https:/

4.0 Procedure for Change Control Management:

 (https:/ /www.
Identification of change:
(https:/ /www. instag
A need for change can be identified as an outcome of (but not limited
to): /twitte facebo ram.co

Implementation of good practices (commonly called as GxP), like

r.com/ ok.co m/gui
manufacturing/
laboratory/documentation/engineering/distribution etc.
Guidel m/gui deline
The recommendation in product quality review.
ineSop deline. sop/?
Up-gradation and/or extension of facility, premises, process,
equipment & utility.
) sop.9) hl=en)
Self -Inspection (https://guideline-sop.com/self-inspection-
internal-audit/), external audit, complaint investigation, or
improvement program.

Regulatory changes, Pharmacopeial updates, marketing

authorization need.
Classification of Change:

Critical Changes:

Change which has a significant impact on product quality and patient

safety shall be classified as Critical changes.

This covers the Introduction of the new dosage form in an existing

qualified facility,

Change of Water system/HVAC System etc.

Major changes :

A change is likely to have a significant impact on quality attributes

(safety, identity, strength, purity, quality) either on a process, material,
product, procedure, utility.

This covers the design change in the existing facility, HVAC, Purified
water & generation system, and introduction of new
equipment/replacement of existing equipment with a new one in an
existing qualified facility.

Minor changes:


 A change is unlikely to have a detectable impact on the quality
attribute (safety, identity, strength, purity, quality) on a process,
material, product, and procedure.

Initiation of Change control:

Initiating department shall initiate the change control form (Annexure

I), after taking the controlled copy from QA.

QA shall issue the change control number and login shall be done in
Annexure-III.

The initiator shall collect requisite information to initiate the change

control.

The existing / proposed activity shall be written under specified

columns.

A change comparison report, wherever required, shall be prepared and

shall enclose with change control.

The reason for change shall be defined in the change control under the
specified column.

The reference of change shall be written under column “reference” and

if required copy shall be attached with change control.

A risk analysis report for all critical & major changes shall be prepared
following SOPfor “Quality Risk Management
(https://www.pharmabeginers.com/quality-risk-management/)” if
necessary and the same shall be enclosed with change control.

The initiator shall forward, the duly filled and signed change control
along with enclosures to the Head of Department/designee for
evaluation and approval.

For all major & critical changes (If required) the initiator shall prepare a
change implementation plan where applicable and that shall be
enclosed with change control.

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.

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.

The first level of evaluation of change control by QA:

Designated QA personnel shall review the change control and attached

documents for correctness.

If the change request needs further clarification or justification, shall

be returned to the initiator (reconsideration) for corrections.

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.

Second level evaluation of change control by Impact Assessment

Team:

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.

IAT shall be decided, based on the recommendation from the initiating

department head, and impact assessment shall be done as per
Annexure-II.

If required DRA shall inform the authority about the change where
approval from the regulatory authority shall be taken prior to
implementation.

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.

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:

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.

Head QA put their comment in change control and classify the change
as minor/major/critical. 
 Approval of change control:

Head QA shall review the comments made in the change control.

Head QA shall approve/reject the change as per their assessment.

QA Head shall put their comment in change control.

After Head QA approval Change control shall be shared (if applicable)

to the customer, MA holder/PL/QP for review, and final approval before
implementation of the proposed change.

Assigning of Activity / Task for Implementation:

Designated QA personnel shall list out the activities to be completed

with the target completion date, name of the responsible
person/department for assigning activity/action plan (Annexure-II)
based on the overall assessment.

Upon completion of the activity, the impacted department shall inform

QA with supporting/changed documents for review.

The initiator shall inform QA about the implementation of

change/completion of the activity to close the change control.

Tracking and Reporting by QA:

A monthly review shall be conducted to evaluate, track activity

completion, and implementation.

QA shall write the details like change effective date, first effective
product (if any) / or first effective batch (if any), and verify.

If the change control could not be implemented fully within the

stipulated period of three months, Concerned Person/Department
responsible for the completion of activity shall request for period
extension (Annexure-IV) through their head of department, who shall
review the extension request and put their comment/justification for
the delay in implementation.

Note: If the proposed changes are with respect to the introduction of a new
product in the facility/Modification of facility then the TCD can be taken up
to 1 year. Further, if the activity is not completed within 1 year, a Request for
period extension (Annexure-IV) shall be initiated by the concerned
person/department.

QA shall assess the impact of delay in the committed action plan, and
may approve or reject the “Period Extension Request” as applicable.

Accordingly, a decision on change request shall be taken by Head QA

in consultation with the relevant department head. 
 Post-implementation effectiveness checks:

After the implementation of change, the QA designee shall carry “Post

effective evaluation” of the change implemented by suitable means
which may include but not limited to evaluation of the results of
studies/activities carried out during change implementation.

Post-effective evaluation needs to be done to check whether the

objective of the change has been achieved and to verify that the quality
parameters are not affected.

After satisfactory post-effective evaluation and availability of all

enclosures/attachments, Head QA shall finally approve the change for
regularization (closure of change)

After final approval (closure of change), respective stakeholders like QP

/ MA Holder / Customer shall be intimated, where applicable.

A copy of evidence (intimation) shall be attached with closed

change control.

A change control shall be preferably closed within three (3) months

after approval. If a change is related to the manufacturing processes,
the impact of change shall be evaluated periodically (more frequently)
to ensure that the stability results are under control, in case of any
insignificant effect of change, the change implemented shall be
immediately reversed and such information shall be floated to all
concerned (QP / MA holder / Regulatory Authority/customer as
applicable).

If a change control is processed for change in premises, equipment, or

any such matter, where it is not feasible to complete all activities
within three months,

Exceptionally the change request may be kept open with

remark/justification and shall be monitored through
appropriate manner under the supervision of Head – QA /
Designee.

Note: This provision is made considering those changes, where “prior

approval” is needed from concerned regulatory agency / civil construction
department, the change control shall be closed after receipt of
consents/orders from concerned regulatory agency / civil construction
department.

Details of change control shall be recorded in the “Change Control Log”

(Annexure-III) at the respective locations where the change control is
logged.


 If there is any deviation observed during the implementation of
change, it changes be handled following SOP for “Deviation / Incident
Management (https://www.pharmabeginers.com/sop-for-deviation-
incident-management/)” and CAPA shall be handled following SOP for
“Corrective and Preventive Action
(https://www.pharmabeginers.com/sop-for-corrective-and-preventive-
action-capa/)”.

Head – QA shall ensure the implementation of the change control

system at the location.

Trending of Change control:

Continuous trending of the change control shall be carried out.

QA shall carry out the trend analysis for all the whole year change
control, at the beginning of the next year.

A copy of the trend analysis shall be forwarded to Head QA.

The trending shall be carried out for the changes to be done as minor,
major, and critical changes.

However, the trending of the major and critical changes shall be done,
like facility-related, document related, product related, Machine
related, etc.

5.0 Reference (S)

The Rules Governing Medicinal Products in the European Union:

Volume 4, EUGMP
Medicinal Products for Human and Veterinary Use. Chapter 4:
Documentation.

The Rules Governing Medicinal Products in the European Union:

Volume 4, EUGMP
Medicinal Products for Human and Veterinary Use. Chapter 1:
Pharmaceutical Quality System.

Schedule M.

WHO TRS/908, Annexure -4.

6.0 Glossary

Change : A change is an improvement, extension, modification,

relocation, the introduction of discontinuation of facility,
equipment, utilities, system, material, product, process, and
related documents

SOP : Standard Operating Procedure.


IAT : Impact assessment team

QP : Qualified Person

CAPA : Corrective Action and Preventive Action

IT : Information technology

QA : Quality Assurance

QC : Quality Control

HR : Human Resource

7.0 Annexure (S)

Annexure – I: Change Control Form.

Change Control No: CC / Issuance

Date:………………..

(To be filled by QA Department)

Originating :
Department

Originator :

(Name) Sign Date

Title of :
Change

Description of Activity:

1. Existing Activity :

2. Proposed Activity :

3. Reference (s) :

4. Risk Analysis (attach approved risk analysis, if any)

Outcome:

The action of Risk Assessment (if any): 

5. Reason for Change :

(Originated
By)

6. Approval / Rejection

Comments:

(Originating Dept.
Head)

7. Evaluation of proposed changes (To be filled by QA):

A. Review of proposed changes:

(QA) Sign/Date

Check impact on Following Yes/No/NA Comments

B. Impact Assessment: Check impact on the following:

Equipment/Utilities/Instrument /facility

Manufacturing process/Formula / Batch

size

MFR/BMR/BPR/BOM

Artwork / Item codes

Standard Operating Procedure / Formats (list

the other impacted procedures)

Raw Material / Packing Material

VMP / Calibration master plan

Process Validation / Cleaning validation

Qualification (DQ/IQ/OQ/PQ)

Check impact on Following Yes/No/NA Comments


Check impact on Following Yes/No/NA Comments

Stability Study

Drawings / Layouts

Technical agreement with

customers/suppliers

Specification / STP

Training Requirement

Area/step/document needs to be evaluated

Assessment of risk in connection to the

proposed change

Analytical Method Validation

License

Any other (Specify)

8. QA Comments :

Sign. & Date

9. QA shall forward the change control to the following concerned

department (wherever applicable):

QA/QC/Production/Engineering/HR/Store/IT/DRA/Purchase/Others______

Impact Assessment Team:

S. No. Name Department

10. Comments and Impact analysis of IAT (if required attach the separate
sheet)

Sr. Department Impact Analysis / Comments Responsibility

No.


11. Action Items

(attach separate sheet if required)

Name of activity / Person Name / Target

Document Department Completion Date

13. Head QA: Approval / Rejection.

Classify the change control: Critical Major Minor

Assessment Checks Tick where Remarks:

applicable
( Specify in details)

Co-ordination with QP, DRA

& Marketing Authorization
for notification to
Regulatory Authorities

Stability to be charged

Relevant documents (MFR

/ BMR / BPR /
Specification) to be
changed

Validation Required

Qualification Required

Training to be given

Issuance of revised
Document

Others

Comments:

15. Tracking & Reporting:


Details Tick (Ö) Remark (if any)
wherever
applicable

1)

Periodic review
for checking 2)

change control

3)

Change Effective From:

Effective Product Name (if any):

Effective Batch No. (if any):

Verified By QA:

16. Action Plan Verification:

Sr. Name of Target Actual Verified By Enclosure

No. activity/Document Completion Completion
(Attached/Not
date date
Attached)

17. Post effective evaluation:

Results (if applicable) Comments

Results of Validation study/exhibit batch/commercial

batch

Results of stability study

Modification of BMR/BPR / Specification

Results of trail carried out by production

Coordination with RA & Marketing for notification to

regulatory authorities

Results of qualification 
Issuance of new documents

Any other (specify)

18. Final Change Control Approval for Regularization (closing):

Head QA

Sign. & Date

19. Information to Stakeholders by QA: Tick (Ö) wherever applicable:

Annexure-II: Responsibilities of Impact Assessment Team and

impact over Documentation/activity/system.

Nature of change Impact over the Documentation / Activity /

System

Change in 1. BMR
manufacturing
Process/Formula/ 2. Stability study
parameters
3. BOM

4. Filling update (market specific)

5. Process Validation

6. Cleaning Process

7. Cleaning agents

8. Site Change

9. Waste handling

10. Artwork (If the change in composition,

addition/deletion of any ingredient printed as in
label claim)


Nature of change Impact over the Documentation / Activity /
System

Change in Packing 1. BPR

Process/parameters
2. Labeling

3. Container Closure

4. Component preparation

5. Process control

6. Process parameters

7. Cleaning process

8. Cleaning agents

9. Site change

10. Waste handling

11. Stability study

12. Filling (Market Specific)

13. Packing Validation

Change in Materials 1. Specification

(Raw / Packing)
2. Material Code (New or Revised)

3. Supplier/vendor

4. Source

5. Manufacturing site

6. Manufacturing process

7. Shipping and Storage conditions

8. Name and address of suppliers

9. Stability study of first 3 batches

10. Material Equivalency

11. Vendor suitability reports


Nature of change Impact over the Documentation / Activity /
System

Change/modification 1. Design/layouts
in Facility
2. Security Changes

3. Flow of Man, Material, Machine, process

4. Designs of HVAC / AHU’s and area

classifications.

5. Environmental Controls

6. Cleaning process/validations

7. Area Qualification

Change in laboratories 1. Analytical methods

2. Analytical Hardware and Software

3. Specifications of Raw / KSM packing /

intermediate / in-process / finished product.

4. Stability protocols

5. Alert and action levels.

6. Site/facility Change

7. Qualification and Calibrations

(Analyst/equipment/methods)

8. Other procedures i.e. OOS, Lab, Incidents,

OOT, etc.

Change in Equipment / 1. Design / URS

Instruments
2. Layouts.

3. Qualification and calibrations

4. Locations for non-portable equipment.

5. Operating procedures

6. Preventive maintenance Schedules


Nature of change Impact over the Documentation / Activity /
System

Change in Warehouse 1. Storage Conditions

/ Shipping /
Distribution centers 2. Environmental Monitoring

3. Re-packing and labeling activity and

control

4. Shipping conditions and control

5. Temperature and Humidity mapping.

6. Procedural control over receipt, verification,

storage, and distribution.

7. Sampling and cleaning facility for

equipment.

8. Balances and its operational management.

Change in the 1. Hardware and Software affecting GMP

computer system activities.
(hardware and
software)
2. Standalone system affecting GMP activities.

3. Process control, laboratory control, desktop,

Laptop

4. Data Flow and data loss

5. Cabling integrity and data security,

resistance fluctuations.

6. Earthing controls.

7. Computer System Validation (GAMP)


Nature of change Impact over the Documentation / Activity /
System

Change in Utility, 1. Layouts and designs

services, and support
system 2. Qualification and validation

DI water, Purified
3. Periodical calibration and validation
Water, Compressed
gas, Steam, Electrical,
4. Specification and system monitoring
Emergency power,
Security system
5. Operating Procedures

6. SCADA / Software validations.

7. Preventive maintenance

Change in vendors 1. Vendor suitability reports

2. Vendor Qualifications

3. Material equivalency report (for alternative

vendors)

4. Item codes and descriptions

5. BOM

6. Stability study

7. Process Validation

8. Method Validations/verifications.

9. Working/impurity standards.

10. Material de-activation / cleaning procedure

Change in Artwork 1. Packing BOM

2. Material code

3. Specification

4. Physical dimension and machine suitability

5. Shade cards, Print proofs.

6. BPR

Nature of change Impact over the Documentation / Activity /
System

Change in 1. Specifications (RM/PM/FP/SFG)

Market/product
extension to another
market/customer 2. Stability protocols and reports

3. Packing material codes, Artwork, BOM,

Shade Cards

4. Regulatory Filing & Approval

5. Specific requirement in APQR

6. Technical Agreement (commercial and

Quality)

Change in SOP / 1. Training

Formats
2. Impact on other SOPs.

Change in shelf life 1. Stability data

2. Control sample analysis report at proposed

expiry and additional one year / six months (as
per market-specific requirement.

3. Update in SAP, BOM, BMR, BPR,

Specifications, Stability protocols.

4. Shelf life extension protocol and

report.


Nature of change Impact over the Documentation / Activity /
System

Change in 1. Material compliance report with the

specifications / STP proposed specification. (3 batches for RM, 1
batch for PM, 3 batches for FP).

2. Stability report compliance report with the

proposed specification.

3. Change in Specifications / STP.

4. Filing requirement (for specific market)

5. Method Validation/verification

6. Impurities and working standards.

7. Equipment, Instrument, Column, Chemicals,

Reagent availability

Pharmacopeial In addition to Change in Specification and STP,

Changes the following requirements to be assessed.

1. MFR, BMR, BOM

2. BPR, Artwork, PM-BOM

3. Item Code

4. License renewal.

Remark: The above-mentioned checklist for impact assessment is for

reference/guidance only impact on other aspects can be extended based on
the nature of change.

Annexure – III: Change Control Log.

Sr. Initiation Change Initiating Proposed Classification Approval Expected The actual Status
control Dept. Change of Change Date date of date of
Date
No.
No. completion completion


 Annexure-IV: Request for the period extension for the closing of
change control

From : Date :

Change Control No. :

Title of Change Control :

Proposed date of implementation :

Extension required :

Justification / Comments :

Head of Department

Sig. & Date

Extension Approved / Rejected

Comments:

Head QA

Sig. & Date

*****************************************END***********************************
******

Janki Singh (Https://Guideline-

Sop.Com/Author/Janki-Singh/)
Mrs. Janki Singh is the professional pharmaceuticals
(https://guidelin
Blogger. She has already posted more than #1000
e-
articles on varrious topics at different blogging
sop.com/author/
plateforms. Contact : [email protected]
janki-singh/)

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