SOP Guide for Pharma

Tablets: SOP for Handling Non-Conforming Products During Manufacturing – V 2.0

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Tablets: SOP for Handling Non-Conforming Products During Manufacturing – V 2.0

Standard Operating Procedure for Handling Non-Conforming Products During Manufacturing

Department Tablet
SOP No. SOP/TAB/218/2025
Supersedes SOP/TAB/218/2022
Page No. Page 1 of 5
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

This SOP defines the procedures for identifying, handling, and resolving non-conforming products during the tablet manufacturing process. Its goal is to ensure that non-conforming products are properly managed to prevent their distribution and to improve overall product quality.

2. Scope

This SOP applies to all non-conforming products detected during tablet manufacturing, including raw materials, intermediates, and finished tablets. It covers all activities from identification, segregation, investigation, corrective actions, and documentation.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring that the non-conforming products are properly handled, investigated, and resolved according to this SOP. The Production Manager and QC Team are responsible for identifying, segregating, and reporting non-conformances.

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5. Procedure

5.1 Identification and Segregation of Non-Conforming Products

  1. Identify non-conforming products through in-process inspections, QC testing, or visual examination during manufacturing (e.g., tablets failing hardness or disintegration testing).
  2. Immediately segregate non-conforming products from conforming products to prevent cross-contamination or accidental release.
  3. Label the non-conforming products clearly with a “Non-Conforming Product” label and place them in a designated quarantine area.
  4. Document the details of the non-conformance, including the batch number, product name, and nature of the non-conformance (Annexure-1).

5.2 Investigation of Non-Conformance

  1. The QC Team investigates the root cause of the non-conformance by reviewing batch records, conducting product testing, and analyzing the manufacturing process (Annexure-2).
  2. Use appropriate investigative techniques such as Root Cause Analysis (RCA) to identify the underlying cause of the non-conformance (Annexure-3).
  3. Document all findings from the investigation, including potential causes, impacts, and corrective action recommendations (Annexure-4).

5.3 Corrective Actions

  1. Develop corrective actions based on the investigation findings to address the root cause and prevent recurrence of the non-conformance (Annexure-5).
  2. Implement corrective actions as soon as possible and document all actions taken (Annexure-6).
  3. Verify the effectiveness of corrective actions by conducting follow-up inspections and testing of products produced after implementation (Annexure-7).
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5.4 Reprocessing or Disposition of Non-Conforming Products

  1. If a non-conforming product can be reprocessed or reworked to meet quality specifications, provide detailed instructions on the steps to follow (e.g., re-blending, re-compressing, or re-coating) (Annexure-8).
  2. If the non-conforming product cannot be reprocessed or reworked, it must be properly disposed of according to the company’s waste disposal procedures (Annexure-9).
  3. Ensure that all reprocessed or disposed products are documented appropriately, with proper tracking and accountability (Annexure-10).

5.5 Documentation and Record Keeping

  1. Ensure that all records related to non-conforming products, investigations, corrective actions, and reprocessing or disposal are documented and securely stored (Annexure-11).
  2. Retain all records for a minimum of 5 years or as required by applicable regulations.

6. Abbreviations

7. Documents

  1. Non-Conformance Report (Annexure-1)
  2. Investigation Report (Annexure-2)
  3. Root Cause Analysis Report (Annexure-3)
  4. Corrective Action Plan (Annexure-4)
  5. Corrective Action Implementation Record (Annexure-5)
  6. Reprocessing Instructions (Annexure-6)
  7. Disposal Records (Annexure-7)
  8. Reprocessing and Disposal Documentation (Annexure-8)
  9. Non-Conformance Documentation (Annexure-9)

8. References

9. SOP Version

Version: 2.0

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10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Non-Conformance Report

Non-Conformance ID Description Batch Number Action Taken
NC001 Potency Out of Specification Batch123 Recalibrated equipment and retested

Annexure-2: Investigation Report

Investigation ID Findings Corrective Action
INV001 Improper calibration of equipment Recalibrate equipment and perform routine checks

Annexure-3: Root Cause Analysis Report

Cause ID Root Cause Description Corrective Action
RCA001 Inconsistent calibration of tablet hardness tester Establish routine calibration schedule

Annexure-4: Corrective Action Plan

Action ID Action Description Completion Date
CAP001 Recalibrate equipment 06/03/2026

Annexure-5: Corrective Action Implementation Record

Action ID Action Implemented By Result
CAP001 Jane Smith Successfully recalibrated equipment

Annexure-6: Reprocessing Instructions

Batch Number Reprocessing Instructions Completion Date
Batch123 Re-blend and compress 06/03/2026

Annexure-7: Disposal Records

Batch Number Disposal Method Disposal Date
Batch123 Incineration 06/03/2026

Annexure-8: Reprocessing and Disposal Documentation

Batch Number Action Taken Completion Date
Batch123 Reprocessing completed 06/03/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP creation New process QA Head
01/02/2025 2.0 Added documentation and tracking requirements Annual review QA Head
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