Procedure

5.1 Identification and Reporting of Deviations

1. If a deviation occurs during tablet production, the production operator must immediately stop the process if necessary to avoid further impact and report the issue to the QA and QC teams.
2. The operator should document the deviation in the batch record, providing a detailed description of the issue, including the time, affected process, and possible causes.
3. If the deviation may affect the product’s quality or safety, notify the QA team immediately for further action.

5.2 Investigation of Deviation

1. The QA team, in collaboration with the relevant departments (e.g., production, QC), will investigate the root cause of the deviation.
2. Investigate all potential factors contributing to the deviation, including raw materials, equipment, procedures, and human errors.
3. If required, perform testing or re-sampling to evaluate the impact of the deviation on the quality of the batch.
4. Document all findings of the investigation in the deviation report (Annexure-1).

5.3 Assessment of Impact

1. Evaluate the potential impact of the deviation on the quality and safety of the batch. If the deviation is deemed to compromise the batch quality, the batch may need to be rejected or reworked.
2. Determine if the deviation affects only the current batch or if it could potentially impact future batches.
3. If necessary, consult with regulatory authorities to assess the impact on compliance and product approval.

5.4 Corrective Actions

1. Based on the investigation, corrective actions must be taken to prevent recurrence of the deviation.
2. Corrective actions may include:
   • Re-calibration of equipment.
   • Additional training for personnel.
   • Review and update of production procedures or batch records.
   • Replacement of raw materials or components if found to be faulty.
3. Document all corrective actions taken in the deviation report, and ensure they are reviewed and approved by QA before implementation.

5.5 Preventive Actions

1. Along with corrective actions, preventive actions must be identified to prevent similar deviations from occurring in the future.
2. Preventive actions could include changes in process controls, additional checks during production, or improvements to equipment maintenance schedules.
3. Implement preventive actions and ensure they are communicated to all relevant departments. Document these actions in the preventive action plan (Annexure-2).

5.6 Re-evaluation and Batch Disposition

1. Once corrective and preventive actions are implemented, conduct a re-evaluation to verify that the deviation has been resolved and that the process is functioning as expected.
2. After the re-evaluation, the batch is either released for the next stage of production or disposed of if deemed non-compliant.
3. Ensure that all documentation related to the deviation is finalized, signed off, and stored in compliance with the company’s record retention policy.

5.7 Documentation and Record Keeping

1. Document all deviations, investigations, corrective actions, and preventive actions in the deviation report (Annexure-1) and preventive action plan (Annexure-2).
2. Ensure that all records are signed off by the responsible personnel and retained according to the company’s document retention policy.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Deviation Report (Annexure-1)
2. Preventive Action Plan (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Deviation Management Guidelines
• USP <701> – Guidelines for Tablet 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: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Deviation in compression force	Re-calibrated the compression machine and retrained personnel	John Doe

Annexure-2: Preventive Action Plan

Action Plan	Assigned To	Completion Date
Review and update calibration procedures for compression equipment	Jane Smith	30/12/2025

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated deviation management process	Improved investigation and corrective action procedures	QA Head