changes in equipment, facilities, standard operating procedures, raw materials, packaging materials, analytical methods, validation protocols, or production processes.

3. Responsibilities

• Initiator: Identifies and proposes the change.
• Department Head: Reviews feasibility and need for change.
• Quality Assurance: Coordinates the change control process, conducts risk assessment, and ensures compliance with regulatory and GMP requirements.
• Quality Control, Validation, Engineering, Regulatory: Support departments for assessment, implementation, and impact evaluation.
• Change Control Committee (CCC): Final approval of major changes.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that changes are properly evaluated, documented, reviewed, and implemented in compliance with applicable regulatory standards and internal policies.

5. Procedure

5.1 Change Initiation

1. The concerned department raises a Change Control Form (Annexure-1) with details such as:
   • Type of change (Major/Minor)
   • Description of change
   • Justification
   • Documents or areas impacted
2. QA assigns a unique Change Control Number (CCN) in the format CCN/YYYY/XXX.
3. The initiator fills the preliminary details and submits to QA for evaluation.

5.2 Risk Assessment

1. QA organizes a cross-functional meeting with all impacted departments.
2. Risk assessment is conducted using tools like FMEA or risk matrix to evaluate:
   • Impact on product quality
   • Regulatory implications
   • Impact on validation and qualification status
   • Impact on documentation, SOPs, and training
3. Risk level is categorized as Low, Medium, or High and documented in Annexure-2.

5.3 Change Classification

1. Changes are categorized as:
   • Minor: No impact on product quality or regulatory filing. Example: typo correction in SOP.
   • Major: Impact on validation, product quality, regulatory dossier. Example: new equipment, formula change.
2. Major changes require Change Control Committee (CCC) approval.

5.4 Change Implementation Plan

1. QA prepares an implementation plan including:
   • Responsibility matrix
   • Timelines
   • Documents to be updated
   • Qualification/validation required
2. Training is imparted if procedures are modified.
3. All changes are implemented according to approved plan with proper documentation.

5.5 Verification and Closure

1. Post-implementation, QA verifies:
   • All impacted SOPs, batch records, logbooks are revised
   • Validations are successfully completed
   • Training records are in place
2. QA signs the Change Control Closure Report (Annexure-3).
3. All documentation is archived and retained as per document retention policy.

6. Abbreviations

• CCN: Change Control Number
• CCC: Change Control Committee
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• FMEA: Failure Modes and Effects Analysis

7. Documents

1. Change Control Form – Annexure-1
2. Risk Assessment Form – Annexure-2
3. Change Control Closure Report – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Current Good Manufacturing Practice
• EU GMP Chapter 1 – Pharmaceutical Quality System
• WHO TRS 981 Annex 3

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Change Control Form

CCN	CCN/2025/032
Initiator	Ravi Kumar
Change Description	Upgrade of visual inspection equipment
Justification	Improved defect detection capability

Annexure-2: Risk Assessment Summary

Risk Area	Impact	Probability	Risk Level
Product Quality	Moderate	Low	Medium
Validation	High	Medium	High

Annexure-3: Change Control Closure

CCN	CCN/2025/032
Implemented On	21/06/2025
Closed By	QA Manager
Closure Date	22/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/04/2022	1.0	Initial version issued	New SOP	Head QA
24/06/2025	2.0	Incorporated detailed risk evaluation and CCC references	Annual Review	Head QA