impact and compliance with applicable laws and guidelines.

4. Accountability

The Production Manager is accountable for initiating the change control process and ensuring that the production team follows the proper procedures. The QC Manager is responsible for evaluating the impact on product quality, while the QA Manager is responsible for final approval and ensuring compliance with this SOP.

5. Procedure

5.1 Initiating a Change Request

1. Any proposed change to the manufacturing process, materials, equipment, or testing methods must be documented in a Change Request Form (Annexure-1).
2. The Change Request Form should include the following details:
   • Description of the proposed change
   • Reason for the change
   • Potential impact on product quality, safety, and compliance
   • Proposed timeline for implementation
   • Responsible parties for implementing the change
3. The Production Team must submit the Change Request Form to the QA team for evaluation.

5.2 Evaluating the Change

1. The QA team reviews the Change Request Form and evaluates the potential impact of the proposed change on product quality, safety, and regulatory compliance.
2. QC must conduct any required testing, such as stability tests or microbial testing, to assess the impact of the change on the cream product.
3. If the proposed change could potentially affect the final product’s specifications, a risk assessment must be conducted, and additional validation or qualification steps may be required.
4. If the change affects regulatory compliance (e.g., packaging changes, formulation alterations), Regulatory Affairs must assess the change for regulatory impact and update relevant documentation as necessary.

5.3 Approving the Change

1. If the proposed change is deemed acceptable by the QA, QC, and Regulatory Affairs teams, the QA Manager approves the change and issues a Change Control Approval Form (Annexure-2).
2. The QA Manager also ensures that any necessary training or procedure updates are completed before the change is implemented.
3. If the change is not approved, the Change Request Form is returned to the Production Team with a request for further clarification or revision. The reason for rejection must be documented.

5.4 Implementing the Change

1. Once the change is approved, the Production Team is responsible for implementing the change according to the defined procedure or timeline.
2. Ensure that all affected documentation, including Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs), are updated to reflect the change.
3. Conduct any necessary re-validation or re-qualification of equipment, processes, or materials affected by the change.
4. The change must be communicated to all relevant departments, including Production, QC, and Regulatory Affairs, to ensure consistency and compliance.

5.5 Monitoring and Reviewing the Change

1. After the change is implemented, monitor the affected process for any issues that may arise, including unexpected results or deviations from specifications.
2. If any issues are detected, initiate a deviation report (Annexure-3) and investigate the cause of the problem.
3. Review the effectiveness of the change after a defined period to ensure that the change has achieved the intended outcome and that no adverse effects have been observed in production or product quality.

5.6 Documentation and Record-Keeping

1. Ensure that all Change Request Forms, Change Control Approval Forms, deviation reports, and validation records are properly documented and stored for audit purposes.
2. All records related to the change control process must be retained for at least two years or as per regulatory requirements.
3. Ensure that all changes are tracked in the Change Control Log (Annexure-4) for traceability and accountability.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• BMR: Batch Manufacturing Record
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: Change Request Form
2. Annexure-2: Change Control Approval Form
3. Annexure-3: Deviation Report
4. Annexure-4: Change Control Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Change Control in Pharmaceutical Manufacturing

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 Request Form

Change Description	Reason for Change	Impact Assessment	Proposed Timeline	Responsible Parties
Change in raw material supplier	New supplier offering better price	No impact on product quality	15/02/2026	Production, QA

Annexure-2: Change Control Approval Form

Change Number	Approval Date	Approved By	Remarks
001	26/01/2026	QA Head	Approved for implementation

Annexure-3: Deviation Report

Deviation Description	Corrective Action Taken	Resolved By	Resolution Date
Delay in raw material delivery	Rescheduled production, updated supplier lead time	Procurement Manager	22/01/2026

Annexure-4: Change Control Log

Change Number	Change Description	Status	Approval Date	Implemented By
001	Change in raw material supplier	Approved	26/01/2026	Production Team

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head