compliance with regulatory and GMP requirements.

2. Scope

This SOP applies to all proposed changes in the sterile injectable manufacturing operations, including but not limited to manufacturing process parameters, equipment modifications, analytical methods, packaging components, and site infrastructure.

3. Responsibilities

• Initiator: Proposes the change and provides supporting rationale and documentation.
• QA Department: Coordinates change control process, evaluates risk, and ensures impact assessment.
• Change Control Committee (CCC): Reviews, approves, or rejects changes after thorough evaluation.
• Implementation Team: Executes the change post-approval and validates its effectiveness.

4. Accountability

The Head of Quality Assurance is accountable for overall compliance to the change control process and its documentation.

5. Procedure

5.1 Change Proposal Initiation

1. Any personnel identifying a potential change shall fill the Change Control Request Form (Annexure-1).
2. Include justification, description, and scope of the proposed change.
3. Submit form to QA Department for initial review and registration.
4. QA assigns a unique Change Control ID in the format: CC/YY/XXX.

5.2 Preliminary Evaluation and Risk Assessment

1. QA conducts a risk assessment using ICH Q9 principles (Annexure-2).
2. Determine classification of change: Minor, Major, or Critical.
3. Forward to Change Control Committee for further evaluation.

5.3 Change Control Committee Review

1. CCC reviews:
   • Impact on validation status
   • Regulatory filings
   • Batch records and specifications
   • Product quality and safety
2. Record outcome in Annexure-3: CCC Review Log.
3. If approved, define implementation plan, timelines, and responsible departments.

5.4 Implementation and Documentation

1. Implement the change as per the approved plan.
2. Perform validation if required (e.g., requalification of equipment, process validation).
3. Update all related SOPs, specifications, records, and training logs.

5.5 Verification and Closure

1. QA reviews documentation and verifies successful implementation.
2. Conduct a post-implementation review if necessary.
3. Close the change request formally and update the Change Control Register (Annexure-4).

6. Abbreviations

• SOP: Standard Operating Procedure
• CCC: Change Control Committee
• QA: Quality Assurance
• CC: Change Control
• ICH: International Council for Harmonisation

7. Documents

1. Change Control Request Form – Annexure-1
2. Risk Assessment Sheet – Annexure-2
3. CCC Review Log – Annexure-3
4. Change Control Register – Annexure-4

8. References

• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – CGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Change Control Request Form

Change ID	Date	Requested By	Description	Reason
CC/25/045	01/06/2025	Rajesh Mehta	Replace Filter Unit	Outdated Equipment

Annexure-2: Risk Assessment Sheet

Change ID	Risk Identified	Severity	Probability	Overall Risk
CC/25/045	Impact on filtration integrity	High	Low	Medium

Annexure-3: CCC Review Log

Date	CCC Members	Decision	Remarks
05/06/2025	QA, QC, Prod, Engg	Approved	Proceed with validation

Annexure-4: Change Control Register

Change ID	Date Initiated	Status	Closure Date	Closed By
CC/25/045	01/06/2025	Closed	12/06/2025	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial Release	New SOP	QA Head
18/06/2025	2.0	Updated change classification and committee roles	Periodic Review	QA Head