Document ID: <FRMXXXX>

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Revision No.: <0>
QMS Change Control form Effective Date: <date>
Signature Position Date
Prepared by:
Reviewed by:
Authorised by:

Change Control Form

Edit any check boxes for standard effects of change to be relevant to your types of products and processes.
Refer to QP716 QMS Change Control
CC ID: Date initiated:

Reason for change:

Primary QMS document(s) impacted:

Change level: Proposed date completed:

Scope change – CC ID: Emergency change
(Scope changes must be tracked, reviewed & approved with original
change request)
Linked change – CC ID: Extension
New date:
Section 1: Change Initiation (Completed by the Change Initiator/Department Manager)
Initiator name: Department:
Description of change:

Justification for Compliance New process New product Improvement

change: Other:
Is this change linked to a deviation or CAPA? No Yes. Dev/CAPA ID:
Is this change linked to an audit citation? No Yes. Audit ID:
Does this change affect product? No Yes. Products/product codes:

Does this change affect registration? No Yes. Products/countries:

Has a risk assessment been completed for the proposed Yes. See attached:
change?

No. Justification for no risk assessment (minor changes only):

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Impact assessment (tick all areas impacted by the proposed change)

Starting Starting material New starting material
materials Excipient To be withdrawn
Primary packaging New supplier
GMP consumable New supplier facility/location
(gloves, masks, tubing, etc) Supplier process change (specify):
Other (give details): Change to existing material
No impact

Change must be assessed by API Sourcing, Supplier Assurance, QA (as appropriate)

Manufacturing New process or in-process Cleaning
control Packing
Change to existing process or Inspecting
in-process control Other:
Obsolete process or in-process
control
Alternate equipment
No impact

Change must be assessed by Manufacturing, QA (as appropriate)

Packing Carton New packaging
Packaging Material To be withdrawn
Label Leaflets Inserts Change existing packaging (specify –
Other (give details): material, size, dimensions etc.)
New Supplier
New supplier facility/location
No impact Change must be assessed by Manufacturing, Vendor Assurance, Procurement (as
appropriate)
Testing New testing procedure Change existing sampling/testing/stability
Change to existing testing protocol or specification
procedure Obsolete sampling/testing/stability protocol or
Obsolete testing procedure specification
No impact Other (give details):

Change must be assessed by QC (Chemistry/Micro/Stability) (as appropriate)

Equipment New manufacturing equipment Decommissioning of existing laboratory
New laboratory equipment equipment
Existing laboratory equipment Decommissioning of existing manufacturing
Existing manufacturing equipment
equipment Change to equipment function (refer
Cleanliness impact automated systems)
Other (give details):
No impact

Change must be assessed by Manufacturing, Engineering, QC, Procurement, QA (as

appropriate)
Facility/utilities Changes to existing facility New services Change to existing services
Decommissioning within Mains water WFI Plant steam
existing facility – Oxygen Compressed air HVAC
Classified Area HEPA filter system CIP/WIP

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Impact assessment (tick all areas impacted by the proposed change)

Non classified Area Dust collection system Electrical
Cleanliness impact required Emergency backup Effluent
Activity performed in Other (specify):
decommissioned state
No impact Activity performed in
commissioned state

Change must be assessed by Manufacturing, Engineering, QA (as appropriate)

IT systems Software/ Data Hardware upgrade
application New software System retirement
Hardware installation Data migration/cleansing
Network Software upgrade Change to equipment function
Network device Patch Other (give details):
Firmware Configuration change GAMP Criticality Assessment
Operating system New hardware ID:
No impact installation

Change must be assessed by IT, QA (as appropriate)

Regulatory Regulatory authority approval/notification
Affairs Implement at risk
(completed by Expected time for approval:
Regulatory
Affairs)

No impact
Training Documents to be trained Type of training method
(completed by
Training)

Time to deliver training: Number trainees:

Trainer:
Supporting Online/presentations (specify):
training materials: Handouts (specify):
No impact
Exercises (specify):
Other (give details):

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Impact assessment (tick all areas impacted by the proposed change)

Documentation Doc. No. Title Version Type of change
(attach (new/ update/
additional obsolete)
pages if
required)

No impact
Validation Doc. No. Title Version Type of change
documents (new/ update/
(attach obsolete)
additional
pages if
required)

No impact

Impact approval (all areas impacted by the change must be reviewed and approved by the
relevant department manager or delegate)
Area Name Initial & Implementation requirements
Date
Material
Sourcing
Calibration
Cleaning
Dispensary
Engineering &
maintenance
Equipment
qualification
Facility/utility
qualification
IT
Labelling
Manufacturing
New product
launch
Packing
Procurement
Product
Development
QC Chemistry
QC
Microbiology
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Impact approval (all areas impacted by the change must be reviewed and approved by the
relevant department manager or delegate)
Area Name Initial & Implementation requirements
Date
QC Stability
QA
Regulatory
Affairs
Training (QA)
Validation
Supplier
Assurance (QA)
Warehouse
Other:

Implementation plan (Must address all implementation requirements from each area. Attach
additional pages as required)
Does this change require phased implementation? Yes No
Implementation plan attached? Yes No – describe below.
Action Responsible Due Date

Section 2. Change Initiation Approval

Department Manager: Signature: Date:
Dept. Manager assigned as Change
Yes No. Delegate name:
Owner?
(Forward the change control request to QA for review prior to assessment by the CCC)

Section 3. Change Control Committee - Approval to Implement

Approved to implement Approved with other requirements. Details:

Rejected. Justification:

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Section 3. Change Control Committee - Approval to Implement

Representative Name Signature Position Date
AP
QA
Training
Regulatory
Affairs

Section 4: Cancellation or Extension

Type of action: Cancellation Extension
Reason:
Affected areas: Date notified:
Requested by: Date:
Approved Rejected. Reason for rejection:
Approved by (QA): Date:

Section 5. Emergency Change

Does product require quarantining for the emergency change? Yes No
Batch to be held until QA notified? Batch No.: Yes No
QA verbally notified of proposed actions? Date: Yes No
Verbal QA approval for emergency change: Yes No
QA Manager/AP: Signature: Date:

Section 6. Evidence of Implementation

Documents issued and effective Effective date: NA
Training completed Training date: NA
Validation/qualification complete Approved report attached? Yes No NA
Regulatory Affairs requirements complete Approved report attached? Yes No NA
QA Change Control Register record finalised
Effectiveness of change required to be Date to be verified: CAPA/Audit ID:
verified?
Other evidence:

Comments:

QA confirmation performed by: Signature: Date:

Section 7. Closeout
QA Manager: Signature: Date:

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Document Information
Revision History
Revision Modified by Change Description of Change
Control No.
01

DOCUMENT END

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