and ensuring that deviation reports are properly documented and resolved.

Maintenance Team: Responsible for investigating equipment-related deviations and providing support for corrective actions related to equipment malfunction.

4. Accountability

The Manufacturing Manager is accountable for ensuring that deviation reports are created, documented, and resolved in a timely manner according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identification of Deviation

1. During the production process, any deviation from the expected procedure, specification, or product quality must be immediately identified and reported by the production team. Common types of deviations include:
   • Out-of-specification product characteristics (e.g., fill weight, pressure)
   • Equipment malfunctions or failures
   • Deviation from approved procedures or operating parameters
   • Raw material or component shortages
   • Contamination risks or potential cross-contamination
2. Deviations must be recorded in the Deviation Report Log (Annexure-1), with as much detail as possible, including:
   • Time and date of the deviation
   • Operator or shift responsible
   • Specifics of the deviation
   • Immediate actions taken (if any)

5.2. Reporting the Deviation

1. Once a deviation is identified, the production team must notify the QC team immediately. The QC team will then assess the situation and determine if further action is required, such as halting production or initiating an investigation.
2. The Deviation Report (Annexure-1) must be filled out thoroughly by the production team, including the following:
   • Description of the deviation
   • Possible causes of the deviation
   • Any immediate corrective actions taken to mitigate the deviation
   • Identification of any affected products or batches
   • Operator and supervisory personnel involved
3. In the case of significant deviations, the manufacturing process may need to be halted until the issue is resolved and the cause of the deviation is fully understood.

5.3. Investigating the Deviation

1. The QC team is responsible for investigating the deviation. The investigation should include:
   • Identifying the root cause of the deviation (e.g., equipment malfunction, process variation, human error, material defect).
   • Reviewing the process parameters, equipment settings, and materials used during the production run.
   • Examining operator logs, batch records, and any other relevant documentation to identify the cause.
2. If the cause is not immediately clear, the QC team should escalate the issue to the relevant department (e.g., Maintenance, Engineering, or Materials Management) for further investigation.
3. Once the root cause is identified, the QC team should recommend corrective actions to address the issue and prevent future occurrences.

5.4. Corrective Actions and Preventive Measures

1. Based on the findings from the investigation, corrective actions must be implemented to resolve the deviation and prevent its recurrence. Corrective actions may include:
   • Adjustment of process parameters
   • Repair or recalibration of equipment
   • Review and retraining of personnel
   • Modification of raw material specifications or sources
2. The effectiveness of corrective actions must be verified by re-assessing the affected batch or process and monitoring subsequent production runs.
3. Preventive measures should also be implemented to minimize the risk of similar deviations occurring in the future. Preventive actions may include process adjustments, updated procedures, or enhanced training programs for operators.

5.5. Documentation and Record-Keeping

1. All deviation reports, including the initial report, investigation findings, corrective actions, and preventive measures, must be documented in the Deviation Report Log (Annexure-1).
2. Ensure that all supporting documentation, such as batch records, equipment calibration logs, and material inspection records, is attached to the deviation report for comprehensive documentation.
3. All deviation reports must be reviewed and approved by the QC team and signed off by the Manufacturing Manager or Supervisor before closure.
4. All deviation reports and associated records must be stored securely in the document management system for future reference and regulatory inspections.

5.6. Review and Closure of Deviation Reports

1. The QC team should review all deviation reports to ensure that:
   • The root cause has been identified and adequately addressed.
   • Corrective actions and preventive measures have been implemented effectively.
   • The affected product or batch has been appropriately assessed and cleared for release (if applicable).
2. Once the deviation report is complete and all corrective actions have been implemented, the report should be closed and archived.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Deviation Report Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Corrective Action Implementation Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report Log

Deviation ID	Deviation Description	Corrective Action	Operator Name	Approval
DEV-12345	Out-of-spec fill weight	Re-calibrated filling machine	Rajesh Patel	Approved

Annexure-2: Corrective Action Log

Deviation ID	Corrective Action Description	Implementation Date	Operator Name	Outcome
DEV-12345	Adjusted machine settings	07/02/2025	Rajesh Patel	Resolved

Annexure-3: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
FILL-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-4: Corrective Action Implementation Log

Deviation ID	Corrective Action	Implementation Date	Operator Name	Approval
DEV-12345	Adjusted machine settings	07/02/2025	Rajesh Patel	Approved

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated deviation reporting procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures