methods, and computerized systems within the API manufacturing plant.

3. Responsibilities

• Change Initiator: Raise the Change Control Request Form with appropriate justification.
• Department Head: Review technical feasibility and operational impact.
• QA Head: Evaluate regulatory and quality impact; coordinate change control system.
• Change Control Committee: Approve or reject changes and oversee implementation.

4. Accountability

The Head of Quality Assurance is accountable for the administration of the change control system, final approval of change controls, and verification of implementation effectiveness.

5. Procedure

5.1 Types of Change

• Major Change: Likely to affect product quality or regulatory filings (e.g., formulation changes, new equipment).
• Minor Change: Limited impact, requires internal documentation (e.g., label text correction).
• Temporary Change: Time-bound or one-time deviation from a standard process (requires justification and timeline).

5.2 Initiation of Change

1. The concerned department shall fill out a Change Control Request Form (Annexure-1).
2. The form shall include:
   • Details of proposed change
   • Justification and rationale
   • Classification (Major/Minor/Temporary)
   • Expected implementation date
3. Submit the form to QA for registration and evaluation.

5.3 Change Control Register

1. QA assigns a unique CCR number (e.g., CCR/2025/017).
2. Enter all details in the Change Control Register (Annexure-2).

5.4 Evaluation and Impact Assessment

1. The QA team shall assess:
   • Impact on validated systems
   • Impact on regulatory filings
   • Need for requalification or revalidation
   • Training and documentation updates
2. Departmental review shall include:
   • Engineering – Facility or utility modifications
   • QC – Analytical method or equipment impact
   • Production – Impact on process flow or batch yield
3. Complete the Impact Assessment Sheet (Annexure-3).

5.5 Review by Change Control Committee

1. The QA Head shall convene a Change Control Committee (CCC) meeting for review.
2. CCC shall include representatives from QA, QC, Production, Engineering, Regulatory Affairs, and Warehouse.
3. The committee decides:
   • Approval
   • Rejection with reasons
   • Modification before re-submission

5.6 Implementation

1. Upon approval, implementation shall be done as per approved action plan.
2. QA shall oversee:
   • Equipment requalification
   • Document revision and issuance
   • Process revalidation (if needed)
   • Training to concerned staff
3. Document implementation evidence in the Change Control Implementation Log (Annexure-4).

5.7 Effectiveness Verification and Closure

1. After implementation, QA performs effectiveness verification to confirm:
   • No adverse impact on product/process
   • Change is working as intended
2. QA Head signs the Change Control Closure Form (Annexure-5).
3. Mark CCR as “Closed” in the Change Control Register.

5.8 Deviation or CAPA Linkage

1. If a change arises from a deviation, link the CCR number with the deviation or CAPA number for traceability.
2. Ensure CAPA closure before final CCR closure.

5.9 Archiving and Review

1. All CCR documentation shall be archived for a minimum of 5 years.
2. QA shall trend all changes and present analysis in quarterly Quality Review Meetings.

6. Abbreviations

• CCR: Change Control Request
• QA: Quality Assurance
• QC: Quality Control
• CCC: Change Control Committee
• CAPA: Corrective and Preventive Action

7. Documents

1. Change Control Request Form (Annexure-1)
2. Change Control Register (Annexure-2)
3. Impact Assessment Sheet (Annexure-3)
4. Implementation Log (Annexure-4)
5. Change Control Closure Form (Annexure-5)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Subpart B: Organization and Personnel
• EU GMP Guidelines – Chapter 1: Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Change Control Request Form

CCR No.	Date	Proposed Change	Initiator	Type
CCR/2025/017	12/04/2025	Replace SS pipeline with PTFE	Rajesh Kumar	Major

Annexure-2: Change Control Register

CCR No.	Date	Department	Status	Closed On
CCR/2025/017	12/04/2025	Production	Open	—

Annexure-3: Impact Assessment Sheet

CCR No.	Area Assessed	Impact	Assessed By
CCR/2025/017	Equipment Qualification	Requalification required	Sunita Reddy

Annexure-4: Implementation Log

CCR No.	Activity	Date	Performed By	Status
CCR/2025/017	Pipeline Replacement	15/04/2025	Maintenance Team	Completed

Annexure-5: Change Control Closure Form

CCR No.	Closure Date	Effectiveness Verified	QA Approval
CCR/2025/017	20/04/2025	Yes	QA Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP System	QA Head
14/04/2025	2.0	Updated annexures and impact evaluation workflow	Process Improvement	QA Head