X Pharmaceutical Manufacturing Company

Quality Assurance Department

Ref. SOP No.:
SOP-XXX Change Control Report
Change Control No.:………………………
Section A – Details of Change (to be completed by Initiator)

1. Originating department :

2. Change proposal & Details:

3.Change category: ❏ Product ❏ Material ❏ Document ❏ Facility

(Select the applicable)
❏ Utility ❏ Equipment ❏ System ❏ Other

4.Subject:

Product name / Material

name / Document title /
Facility/ Utility / System /
Other:
5. Change details:
(Provide maximum details)
Existing condition:

proposed change:

Reason for change(justification):

Supporting documents:

6. Approval
Change originated by (Title/Sign/date) Originating Dept. Manager (Sign/date)

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 X Pharmaceutical Manufacturing Company
Quality Assurance Department
SOP-XXX Change Control Report (Impact assessment & Action plan)
Change Control No.:………………………
Section B – Impact Assessment (to be completed by originating departmental and QA)

1. Departments to be involved in impact assessment

2. Checklist of Affected Documents/Activities

The impacts on below items but not limited to be evaluated and compliance status must be updated as change implementation progresses.

Impacted Target Completion Reviewed by

Items Appropriate action required Responsibility
(YES / NO) Date Date QA/Date
New facility to be designed / developed.
Facility
Existing facility to be modified.
Purified water Purified water to be arranged or to be modified
HVAC HVAC to be arranged or to be modified.
Electricity Electricity to be arranged or to be modified.
Light Light to be arranged or to be modified.
Compressed Compressed air to be arranged or to be
air modified.
Utilities Vacuum Vacuum to be arranged or to be modified.
Gas (CO2, N2, etc.) to be arranged or to be
Gas
modified.
Purified steam to be arranged or to be
Steam
modified.
Exhaust Exhaust to be arranged or to be modified.
Drainage Drainage to be arranged or to be modified.
New drawing to be developed.
Drawing (plant diagrams)
Existing drawing to be amended.
New SOPs to be developed.
SOPs
Existing SOPs to be amended.

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 X Pharmaceutical Manufacturing Company
Quality Assurance Department
Ref. SOP No.:
SOP-XXX Change Control Report (Impact assessment & Action plan)
Change Control No.:………………………
Impacted Target Completion Reviewed by
Items Appropriate action required Responsibility
(YES / NO) Date Date QA/Date
Mfg. POI to be developed or amended.
Batch documents (POIs)
Pkg. POI to be developed or amended.
New specification to be developed.
Specifications
Existing specification to be amended.
New test procedure to be developed.
Test Procedures/Methods
Existing test procedure to be amended.
Logbooks & required documents to be
initiated.
Site master file to be updated.
Other Documents Validation master plan to be updated.
Trend to be monitored /generated.
Protocols to be prepared: Qualification /
Validation / Stability / etc.
APR (Annual Product Review) APR to be updated.
Facility qualification to be performed.
Utility qualification to be performed.
Qualification/requalification
Equipment qualification to be performed.
Instrument qualification to be performed.
Process validation / re-validation to be done.
Cleaning validation / revalidation to be done.
Validation/revalidation Computer system validation / revalidation to
be done.
Method validation / revalidation to be done
Preventive maintenance schedule to be
Preventive maintenance
developed / rescheduled.

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 X Pharmaceutical Manufacturing Company
Quality Assurance Department
Ref. SOP No.:
SOP-XXX Change Control Report (Impact assessment & Action plan)
Change Control No.:………………………
Impacted Target Completion Reviewed by
Items Appropriate action required Responsibility
(YES / NO) Date Date QA/Date
Coding of the area/machine Identification number to be issued.
Calibration Calibration / re-calibration to be done.
New supplier to be approved.
Approved supplier
Supplier to be deleted.
Long term stability data to be arranged.
Stability studies
Accelerated stability data to be arranged.
Temperature to be set / reset.
Humidity to be set / reset.
Environmental control Pressure differential to be set / reset.
Viable particulate matter to be checked.
Non-viable particulate matter to be checked.
Personnel Additional staffs to be arranged / modified.
Training to be arranged.
Training
Re-training to be arranged.
Additional testing to be involved, physical,
chemical, microbial, bioequivalence or clinical.
Sampling / Testing
Retesting to be done.
Microbial testing to be involved.
Existing batches to be reprocessed /repacked.
Stock /inventory Existing batches/stock to be rejected.
Batches to be recalled.
SAP SAP to be updated.

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 X Pharmaceutical Manufacturing Company
Quality Assurance Department
Ref. SOP No.:
SOP-XXX Change Control Report (Impact assessment & Action plan)
Change Control No.:………………………

Impacted Target Completion Reviewed by

Items Appropriate action required Responsibility
(YES / NO) Date Date QA/Date
EHS issues to be addressed.
Rodent cages to be arranged.
Safety
Fire extinguisher / hose to be arranged.
Insecticuter to be fixed.
HR Legal / statutory documents to be arranged.
Other:

(Use the spec to write additional actions / recommendation / explanation for any above)
Comments:

3. Approval
Originating Dept Related Dept Managers Approved by Reviewed & approved by QA Manager
Manager Dept:_ _ _ _ _ _ _ _ _ _ Dept:_ _ _ _ _ _ _ _ _ _ Dept:_ _ _ _ _ _ _ _ _ _ QA Manager (after compliance )

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 X Pharmaceutical Manufacturing Company
Quality Assurance Department

SOP-XXX
Change Control Report (Impact
assessment & Action plan)
Change Control No.:………………………

4. Regulatory Affairs Review & Comments (select the appropriate condition)

Criteria If Required, condition to implement the change

❏ Wait for change implementation.

❏ Required ❏ Do not wait for change implementation.

Client pre-notification
❏ Not required ❏ Client will be notified once approved documents
received after change implementation.

❏ Wait for change implementation.

❏ Required ❏ Do not wait for change implementation.

Client
pre-approval / approval ❏ Not required ❏ Client will be notified once approved documents
received after change implementation.

❏ Wait for change implementation.

❏ Required ❏ Do not wait for change implementation.

Regulatory pre-notification
❏ Not required ❏ Client will be notified once approved documents
received after change implementation.

❏ Wait for change implementation.

❏ Required ❏ Do not wait for change implementation.

Regulatory
pre-approval / approval ❏ Not required ❏ Client will be notified once approved documents
received after change implementation.

Other Comments:

5. Reviewed & Approved by Regulatory Dept. Head :

Name:_ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ Sign/Date:_ _ _ _ _ __ __ _ _ _

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 X Pharmaceutical Manufacturing Company
Quality Assurance Department

SOP-XXX
Change Control Report (Impact
assessment & Action plan)

Section C– Evaluation of Change Proposal (to be completed by Quality Assurance)

1. QA Review & Comments

2. Type of Change (Tick the appropriate) ❏ Major ❏ Minor

3. Reviewed by QA
Title:_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ Sign/date:_ _ _ _ _ __ __ _ _ _ __

4. Assessment of Validity (to be completed by Quality Assurance Manager)

This change may; (9) Sign Date

Be introduced Immediately

Not be Introduced Until @

Be Introduced Subject to the Conditions below @

Not be introduced for the reasons below @

@:

5. Quality Assurance:
The proposed change will be implemented as described above
Title:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Sign/date:_ _ _ _ _ _ _ _ _ _ _ _

Section D – Closeout of Change Control (to be completed by all)

The proposed change was completed. Change impacts were in line to evaluation. All associated actions related to the
change have been completed.

Title Name Sign Date

Originator

Dept. Manager

Quality Assurance

QA Manager
Attachments: (specify if any):
Note: Use change control attachment to write the details if the space found insufficient.

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