unplanned changes related to raw material specifications, manufacturing equipment, batch manufacturing records, facility layouts, and procedures within the Gel Manufacturing department.

3. Responsibilities

• Initiator: Identifies the need for change and initiates the change control form.
• QA Department: Coordinates and evaluates the proposed change for compliance and impact assessment.
• Engineering: Supports equipment-related modifications and validation.
• Production Supervisor: Executes the approved change and documents outcomes.

4. Accountability

The Head of Quality Assurance holds final accountability for change approval and closure, ensuring risk mitigation and proper documentation.

5. Procedure

5.1 Change Control Initiation

1. The user department identifies a change requirement (e.g., process improvement, equipment upgrade, raw material specification revision).
2. Fill the Change Control Request Form (Annexure-1) with the following details:
   • Type of change: Minor/Major/Critical
   • Reason for change
   • Proposed benefits
   • List of impacted documents/processes/equipment
3. Submit the form to QA for further evaluation.

5.2 Impact Assessment

1. QA performs an initial review and assigns the Change Control Number.
2. Conduct a detailed impact assessment involving:
   • Manufacturing
   • Engineering
   • QC
   • Regulatory Affairs (if needed)
3. Assess potential risks related to:
   • Product quality
   • Process integrity
   • Compliance
   • Stability and safety
4. QA documents assessment outcomes in the Change Impact Assessment Form (Annexure-2).

5.3 Approval Process

1. Based on impact assessment, the change request is either:
   • Approved: Implemented as per action plan
   • Rejected: Closed with justification
   • Deferred: Pending further clarification
2. Approval is documented in the Change Control Approval Log (Annexure-3).

5.4 Implementation and Validation

1. The user department implements the approved change as per the defined action plan.
2. Any modification to equipment or process shall be validated before routine use.
3. Training shall be imparted to concerned staff for procedural changes (documented in Annexure-4).

5.5 Closure

1. Post-implementation review is conducted by QA and relevant departments.
2. QA verifies if the change was implemented satisfactorily without any deviation.
3. QA completes the Change Control Closure Section and archives the complete documentation.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• SOP: Standard Operating Procedure

7. Documents

1. Change Control Request Form – Annexure-1
2. Change Impact Assessment Form – Annexure-2
3. Change Control Approval Log – Annexure-3
4. Training Record Form – Annexure-4

8. References

• ICH Q10: Pharmaceutical Quality System
• EU GMP Chapter 1: Pharmaceutical Quality System
• 21 CFR Part 211 – Current Good Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Change Control Request Form

Change Control No.
Initiator Name
Date of Request
Type of Change	Minor / Major / Critical
Description of Change
Reason
Proposed Benefits
Impacted Documents/Process

Annexure-2: Change Impact Assessment Form

Area	Impact	Assessment Notes
Product Quality
Process
Equipment
Regulatory

Annexure-3: Change Control Approval Log

Change Control No.	Status	Approver	Date
	Approved / Rejected / Deferred

Annexure-4: Training Record Form

Employee Name	Designation	Date of Training	Trainer Name	Signature

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Updated to include annexures	Regulatory Enhancement	QA Head