SOP Guide for Pharma

Tablets: SOP for Review and Approval of Process Deviations – V 2.0

Auditor

Tablets: SOP for Review and Approval of Process Deviations – V 2.0

Standard Operating Procedure for Review and Approval of Process Deviations

Department Tablet
SOP No. SOP/TAB/212/2025
Supersedes SOP/TAB/212/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

This SOP outlines the procedure for reviewing and approving process deviations during tablet manufacturing. It ensures that any deviations from approved processes are documented, investigated, and addressed in compliance with GMP and regulatory requirements.

2. Scope

This SOP applies to all deviations from established tablet manufacturing processes, including those related to raw materials, equipment, environmental conditions, and procedures. It covers the review, investigation, approval, and corrective actions associated with process deviations.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring that process deviations are reviewed and approved in compliance with GMP and regulatory standards. The Production Team and Process Owners are responsible for identifying deviations and participating in investigations.

See also  Tablets: SOP for Real-Time Data Logging in In-Process Monitoring - V 2.0

5. Procedure

5.1 Identification of Process Deviations

  1. Identify any deviation from the established tablet manufacturing process, including but not limited to equipment malfunctions, raw material issues, environmental conditions, and procedural non-conformances.
  2. Document the deviation immediately, including the affected process, batch number, date, and a description of the issue (Annexure-1).
  3. Notify the QA Manager and Process Owner of the deviation as soon as it is identified.

5.2 Documentation of Process Deviation

  1. Document the process deviation in the Process Deviation Log (Annexure-2), ensuring that all relevant information is included, such as:
    • Batch number and manufacturing date
    • Description of the deviation
    • Root cause analysis (if known)
    • Impact assessment
  2. Ensure that all entries in the Process Deviation Log are reviewed by the QA team for completeness and accuracy.

5.3 Investigation of Process Deviations

  1. QA will initiate an investigation into the cause of the process deviation, including reviewing the batch records, equipment logs, and environmental conditions during the affected production run (Annexure-3).
  2. Collaborate with the Production Team and Process Owners to identify potential root causes, such as equipment malfunction, raw material defects, or human error.
  3. Use investigation tools such as fishbone diagrams or 5 Whys to determine the root cause of the deviation.

5.4 Corrective Actions

  1. Once the root cause has been identified, implement corrective actions to address the deviation and prevent recurrence. Corrective actions may include:
    • Equipment repairs or recalibrations
    • Changes to raw material specifications or suppliers
    • Process adjustments or employee retraining
  2. Document the corrective actions taken in the Corrective Action Report (Annexure-4) and ensure that they are approved by the QA Manager.
See also  Tablets: SOP for Process Controls in Sustained Release Tablet Manufacturing - V 2.0

5.5 Review and Approval of Process Deviation

  1. The QA Manager and relevant stakeholders, including the Process Owner, must review the investigation results and the corrective actions taken to address the deviation.
  2. Approve the deviation and corrective actions if the investigation is thorough, and the corrective actions are deemed sufficient to prevent recurrence (Annexure-5).
  3. Ensure that the approval is documented, and all records are maintained in accordance with GMP guidelines.

5.6 Communication of Deviation Resolution

  1. Once the process deviation has been resolved and the corrective actions approved, communicate the resolution to the Production Team and other relevant departments.
  2. Update the affected batch records and process documentation to reflect the corrective actions taken.

5.7 Documentation and Record Keeping

  1. Ensure that all documents related to the process deviation, investigation, corrective actions, and approvals are maintained for a minimum of 5 years or as required by regulatory guidelines.
  2. Store all records in a secure and easily accessible location for future audits and inspections (Annexure-6).

6. Abbreviations

7. Documents

  1. Process Deviation Log (Annexure-2)
  2. Root Cause Investigation Report (Annexure-3)
  3. Corrective Action Report (Annexure-4)
  4. Process Deviation Approval Log (Annexure-5)
  5. Process Deviation Records (Annexure-6)
See also  Tablets: SOP for Moisture Barrier Coating for Tablets - V 2.0

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: Process Deviation Log

Batch Number Deviation Description Investigation Date Resolution
Batch-12345 Deviation in coating uniformity 01/03/2026 Corrective action implemented

Annexure-2: Process Deviation Investigation Report

Deviation ID Root Cause Corrective Actions Responsible Person Completion Date
DEV-001 Incorrect coating solution concentration Adjusted formulation Production Lead 05/03/2026

Annexure-3: Corrective Action Report

Action ID Action Description Completion Date
CAP-001 Adjusted coating solution concentration 05/03/2026

Annexure-4: Process Deviation Approval Log

Approval Date Approved By Approval Status
06/03/2026 QA Manager Approved

Annexure-5: Process Deviation Records

Batch Number Deviation Type Action Taken
Batch-12345 Coating Defect Re-formulated coating solution

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 procedure for investigating deviations Clarified responsibilities and actions QA Head
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