is responsible for coordinating the safe handling and movement of these materials.

5. Procedure

5.1 Identification and Documentation of Rejected Materials

1. Approval of Rejection:
   • QA reviews QC test results and documentation before approving the rejection of materials.
   • The Material Rejection Authorization Form (Annexure-1) must be completed and signed by QA.
2. Labeling of Rejected Materials:
   • Warehouse personnel must label rejected materials with:
     • “REJECTED” tag in red
     • Material Name and Batch/Lot Number
     • Reason for Rejection
     • Date of Rejection
   • Ensure all labels are clear, legible, and securely attached to the material containers.

5.2 Preparation for Transportation

1. Securing Rejected Materials:
   • Ensure all containers are sealed, intact, and free from leaks or damage before transportation.
   • For hazardous materials, follow safety protocols, including the use of personal protective equipment (PPE) and proper containment measures.
2. Transport Authorization:
   • Complete the Rejected Material Transport Authorization Form (Annexure-2) and obtain signatures from the QA Manager and Warehouse Manager.

5.3 Transporting Rejected Materials

1. Designated Disposal Route:
   • Transport rejected materials using the designated route from the quarantine area to the disposal area.
   • Ensure the route is free from obstructions and complies with safety regulations.
2. Use of Appropriate Equipment:
   • Use forklifts, trolleys, or other appropriate equipment to move rejected materials safely.
   • Ensure all equipment is in good working condition and suitable for transporting the specific material type.

5.4 Documentation and Record-Keeping

1. Transport Logs:
   • Record all transportation activities in the Rejected Material Transport Log (Annexure-3), including:
     • Date and Time of Transport
     • Material Name and Batch/Lot Number
     • Transport Personnel
     • Receiving Personnel at Disposal Area
2. Final Disposal Documentation:
   • Complete the Rejected Material Disposal Record (Annexure-4) once materials have been transported and accepted in the disposal area.
   • QA must verify and sign off on the disposal records.

5.5 Handling Special Categories of Rejected Materials

1. Hazardous Materials:
   • Follow environmental and safety regulations for the handling and disposal of hazardous materials.
   • Ensure the use of appropriate PPE and containment measures during transportation.
2. Temperature-Sensitive Materials:
   • Maintain cold chain requirements for temperature-sensitive rejected materials until final disposal.
   • Record temperature data in the Temperature Monitoring Log (Annexure-5).

5.6 Training and Compliance Monitoring

1. Personnel Training:
   • All personnel involved in the transportation of rejected materials must be trained in handling procedures and safety protocols.
   • Document training sessions in the Training Log (Annexure-6).
2. Compliance Monitoring:
   • QA conducts periodic audits to ensure compliance with SOPs and regulatory requirements.
   • Document audit findings in the Compliance Audit Log (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment
• APIs: Active Pharmaceutical Ingredients

7. Documents

1. Material Rejection Authorization Form (Annexure-1)
2. Rejected Material Transport Authorization Form (Annexure-2)
3. Rejected Material Transport Log (Annexure-3)
4. Rejected Material Disposal Record (Annexure-4)
5. Temperature Monitoring Log (Annexure-5)
6. Training Log (Annexure-6)
7. Compliance Audit Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO GMP Guidelines for Storage and Disposal of Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Rejection Authorization Form

Date	Material Name	Batch Number	Reason for Rejection	Approved By
01/02/2025	API-X	API-X-2025-001	Failed Purity Test	Anjali Mehta

Annexure-2: Rejected Material Transport Authorization Form

Date	Material Name	Batch Number	Transported By	Approved By (QA)
02/02/2025	API-X	API-X-2025-001	Ravi Kumar	Anjali Mehta

Annexure-3: Rejected Material Transport Log

Date	Material Name	Batch Number	Transported By	Received By (Disposal)
02/02/2025	API-X	API-X-2025-001	Ravi Kumar	Ajay Singh

Annexure-4: Rejected Material Disposal Record

Date	Material Name	Batch Number	Disposed By	Verified By (QA)
03/02/2025	API-X	API-X-2025-001	Disposal Team	Anjali Mehta

Annexure-5: Temperature Monitoring Log

Date	Material Name	Batch Number	Temperature Recorded	Recorded By
02/02/2025	Solvent-Y	SLV-Y-2025-002	5°C	Sunita Sharma

Annexure-6: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
05/02/2025	Handling and Transporting Rejected Materials	QA Manager	Ravi Kumar

Annexure-7: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
06/02/2025	Transport Compliance Audit	Minor Labeling Errors Found	Updated Labeling Procedures	Anjali Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Transport and Disposal Procedures	Regulatory Compliance	QA Head