SOP Guide for Pharma

Tablets: SOP for Deviation Management During Tablet Production – V 2.0

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Tablets: SOP for Deviation Management During Tablet Production – V 2.0

Standard Operating Procedure for Deviation Management During Tablet Production

Department Tablet
SOP No. SOP/TAB/172/2025
Supersedes SOP/TAB/172/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for managing deviations that occur during tablet production, ensuring that all deviations are documented, investigated, and resolved in compliance with GMP and quality standards.

2. Scope

This SOP applies to all deviations encountered during the tablet production process, including raw material issues, equipment malfunctions, and non-conformance to batch specifications.

3. Responsibilities

4. Accountability

The Production Supervisor is accountable for ensuring that deviations are reported and documented promptly. The QA Manager is responsible for overseeing the investigation and ensuring that corrective actions are completed.

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5. 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.
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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.
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6. Abbreviations

7. Documents

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

8. References

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
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