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.

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).

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

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

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

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• GMP Guidelines for Pharmaceutical 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: 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