Standard Operating Procedure for Handling Rejected or Non-Conforming Materials

Department	Capsule Manufacturing
SOP No.	SOP/CM/014/2025
Supersedes	SOP/CM/014/2022
Page No.	Page 1 of 7
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

To establish procedures for the proper handling, documentation, and disposition of rejected or non-conforming materials in capsule manufacturing to ensure product quality and compliance with regulatory standards.

2. Scope

This SOP applies to all rejected or non-conforming materials during the manufacturing and dispensing processes in capsule production, including APIs, excipients, and packaging materials.

3. Responsibilities

• Manufacturing Personnel: Responsible for identifying and segregating non-conforming materials during dispensing or production and documenting them appropriately.
• Quality Control (QC) Team: Responsible for verifying non-conformity, conducting investigations, and ensuring proper handling, testing, and documentation of rejected materials.
• Quality Assurance (QA) Team: Oversees compliance with SOPs, ensures that rejected materials are handled and disposed of in accordance with regulations, and approves final disposition decisions.
• Warehouse Personnel: Responsible for ensuring that rejected materials are segregated, labeled, and stored appropriately in a quarantine area until final disposition is determined.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring that rejected or non-conforming materials are properly segregated and handled. The QA Manager is responsible for overseeing the investigation, documentation, and final disposition of non-conforming materials.

5. Procedure

5.1 Identifying Rejected or Non-Conforming Materials

Identify rejected or non-conforming materials during the manufacturing and dispensing processes:

1. Inspection for Non-Conformance
   1. During dispensing, manufacturing, or storage, identify any materials that do not meet the required specifications (e.g., wrong batch number, incorrect material, damaged packaging, or contamination).
   2. Quality Control (QC) team members should visually inspect all materials to confirm that they conform to the specified requirements.
2. Material Sampling and Testing
   1. If a material is suspected of being non-conforming, conduct the appropriate sampling and testing as outlined in the QC protocols.
   2. If the material fails the testing, it is officially classified as non-conforming.

5.2 Segregation of Rejected Materials

Ensure that rejected or non-conforming materials are segregated to prevent use in manufacturing:

1. Quarantine Area
   1. Immediately transfer any rejected or non-conforming materials to a designated quarantine area to prevent them from being mistakenly used in production.
   2. Ensure that the quarantine area is clearly labeled as “Non-Conforming” and is physically separated from materials approved for use in manufacturing.
2. Labeling of Rejected Materials
   1. Label all rejected materials with a “Rejected” or “Non-Conforming” tag to indicate that they should not be used until further investigation and disposition are conducted.

5.3 Investigation and Documentation of Rejected Materials

Conduct an investigation for each rejected or non-conforming material to determine the cause of the non-conformance:

1. Document the Non-Conformance
   1. Document each non-conformance in the Discrepancy Report (Annexure-1), including the nature of the issue, the material involved, the batch number, and the personnel responsible for identifying the non-conformance.
   2. Record any corrective or preventive actions taken to resolve the issue.
2. Root Cause Analysis
   1. Investigate the root cause of the non-conformance. Possible causes may include improper storage, supplier issues, manufacturing defects, or human error.
   2. Use tools such as fishbone diagrams, 5 Whys, or other problem-solving techniques to identify the underlying cause.
3. Corrective and Preventive Actions (CAPA)
   1. Implement corrective actions to fix the immediate issue and prevent recurrence. These actions may include rework, retraining, or adjustments to procedures.
   2. Document all corrective and preventive actions in the CAPA log and ensure they are reviewed and approved by the QA team.

5.4 Disposition of Rejected Materials

Once the investigation is complete, determine the final disposition of the rejected or non-conforming materials:

1. Rework or Return to Supplier
   1. If the material is reworkable and meets specifications after rework, document the process and release it for use.
   2. If the material is defective and cannot be reworked, initiate a return to the supplier for replacement or credit.
2. Disposal of Non-Conforming Materials
   1. If the material cannot be reworked or returned, dispose of it according to approved procedures and regulatory guidelines for hazardous or non-conforming materials.
   2. Document the disposal method in the Non-Conforming Material Disposal Log (Annexure-2) and obtain approval from the QA team before disposal.

5.5 Final Approval and Documentation

Once the disposition decision is made, ensure all documentation is finalized:

1. Final Documentation
   1. Ensure all relevant documentation (e.g., Discrepancy Report, CAPA log, Non-Conforming Material Disposal Log) is completed and reviewed by the QA team.
   2. Obtain approval from the QA Manager or designee for final disposition decisions.
2. Record Retention
   1. Retain all documentation related to rejected materials, including investigation reports and corrective actions, for the required retention period per regulatory guidelines.
   2. Ensure that these records are accessible for audits or inspections by regulatory agencies.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• API: Active Pharmaceutical Ingredient
• PO: Purchase Order
• CoA: Certificate of Analysis

7. Documents

1. Discrepancy Report (Annexure-1)
2. Non-Conforming Material Disposal Log (Annexure-2)
3. CAPA Log (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Discrepancy Report

Date	Material Name	Batch Number	Issue Description	Corrective Action
04/02/2025	Excipient-789	Batch 23456	Wrong batch received	Returned to supplier for replacement

Annexure-2: Non-Conforming Material Disposal Log

Date	Material Name	Batch Number	Disposition Method	Approved By
06/02/2025	API-123	Batch 56789	Incinerated	QA Head

Annexure-3: CAPA Log

Date	Issue Description	Corrective Action	Preventive Action
07/02/2025	Improper material labeling	Re-labeled material and updated records	Trained staff on correct labeling procedures

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 non-conforming material handling procedures	Standardization and clarity	QA Head