The EHS Manager is responsible for ensuring that all decontamination activities comply with environmental and safety regulations.

5. Procedure

5.1 Identification and Documentation of Contaminated Materials

1. Detection of Contamination:
   • Warehouse personnel must immediately report any signs of contamination, such as leaks, discoloration, unusual odors, or foreign particles.
   • QC will perform preliminary tests to confirm contamination and document findings in the Contamination Detection Log (Annexure-1).
2. Isolation of Contaminated Materials:
   • Move contaminated materials to a designated isolation area within the quarantine zone.
   • Label materials as “CONTAMINATED” with clear indicators, including material name, batch number, and type of contamination.
   • Document isolation in the Contaminated Material Isolation Log (Annexure-2).

5.2 Decontamination Process

1. Selection of Decontamination Method:
   • QA and EHS will determine the appropriate decontamination method based on the type of contamination (e.g., microbial, chemical, or physical contamination).
   • Document the selected method in the Decontamination Plan (Annexure-3).
2. Preparation for Decontamination:
   • Ensure all personnel involved wear appropriate personal protective equipment (PPE).
   • Prepare necessary decontamination agents and equipment as specified in the Material Safety Data Sheet (MSDS).
3. Decontamination Procedure:
   • Follow the specific steps outlined in the Decontamination Plan, which may include:
     • Washing or rinsing with approved solvents or water
     • Using disinfectants for microbial contamination
     • Filtration or centrifugation for physical contaminants
   • Record each step in the Decontamination Activity Log (Annexure-4).

5.3 Post-Decontamination Testing and Verification

1. QC Testing:
   • QC will perform testing to verify the effectiveness of the decontamination process.
   • Document testing results in the Post-Decontamination Testing Log (Annexure-5).
2. QA Review and Approval:
   • QA will review the testing results and approve the release or rejection of the decontaminated materials.
   • If the material passes, complete the Decontaminated Material Release Authorization Form (Annexure-6).
   • If the material fails, proceed with disposal and document in the Contaminated Material Disposal Log (Annexure-7).

5.4 Handling of Non-Recoverable Contaminated Materials

1. Disposal Procedure:
   • Non-recoverable contaminated materials must be disposed of following environmental and regulatory guidelines.
   • Use approved disposal methods and document the disposal process in the Disposal Authorization Form (Annexure-8).
2. Environmental Safety:
   • EHS must oversee disposal activities to ensure environmental safety and compliance.
   • Document any environmental monitoring activities related to disposal in the Environmental Safety Log (Annexure-9).

5.5 Documentation and Record-Keeping

1. Record Maintenance:
   • All records related to decontamination, testing, and disposal must be maintained in compliance with regulatory requirements.
   • Ensure records are reviewed periodically and stored securely in the Decontamination Records Archive (Annexure-10).

5.6 Training and Compliance Monitoring

1. Personnel Training:
   • All personnel involved in decontamination processes must receive specialized training.
   • Document training sessions in the Training Log (Annexure-11).
2. Compliance Audits:
   • QA and EHS will conduct periodic audits of decontamination procedures to ensure compliance.
   • Document audit findings in the Compliance Audit Log (Annexure-12).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• EHS: Environmental Health & Safety
• PPE: Personal Protective Equipment
• MSDS: Material Safety Data Sheet
• APIs: Active Pharmaceutical Ingredients

7. Documents

1. Contamination Detection Log (Annexure-1)
2. Contaminated Material Isolation Log (Annexure-2)
3. Decontamination Plan (Annexure-3)
4. Decontamination Activity Log (Annexure-4)
5. Post-Decontamination Testing Log (Annexure-5)
6. Decontaminated Material Release Authorization Form (Annexure-6)
7. Contaminated Material Disposal Log (Annexure-7)
8. Disposal Authorization Form (Annexure-8)
9. Environmental Safety Log (Annexure-9)
10. Decontamination Records Archive (Annexure-10)
11. Training Log (Annexure-11)
12. Compliance Audit Log (Annexure-12)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO Guidelines for the Safe Handling of Contaminated Materials

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Contamination Detection Log

Date	Material Name	Batch Number	Type of Contamination	Detected By
01/02/2025	API-X	API-X-2025-001	Microbial	Sunita Sharma

Annexure-2: Contaminated Material Isolation Log

Date	Material Name	Batch Number	Isolation Area	Isolated By
01/02/2025	API-X	API-X-2025-001	Quarantine Zone B	Ravi Kumar

Annexure-3: Decontamination Plan

Date	Material Name	Batch Number	Decontamination Method	Approved By
02/02/2025	API-X	API-X-2025-001	Disinfection with Ethanol	Anjali Mehta

Annexure-4: Decontamination Activity Log

Date	Material Name	Batch Number	Activity Performed	Performed By
03/02/2025	API-X	API-X-2025-001	Surface Disinfection	Ravi Kumar

Annexure-5: Post-Decontamination Testing Log

Date	Material Name	Batch Number	Test Conducted	Result	Tested By
04/02/2025	API-X	API-X-2025-001	Microbial Load Test	Pass	Sunita Sharma

Annexure-6: Decontaminated Material Release Authorization Form

Date	Material Name	Batch Number	Released By	Signature
05/02/2025	API-X	API-X-2025-001	Anjali Mehta

Annexure-7: Contaminated Material Disposal Log

Date	Material Name	Batch Number	Disposal Method	Disposed By
05/02/2025	API-Y	API-Y-2025-002	Incineration	Disposal Team

Annexure-8: Disposal Authorization Form

Date	Material Name	Batch Number	Approved By	Signature
05/02/2025	API-Y	API-Y-2025-002	Anjali Mehta

Annexure-9: Environmental Safety Log

Date	Activity	Observations	Verified By
06/02/2025	Post-Disposal Site Inspection	No Environmental Impact Observed	Ravi Kumar

Annexure-10: Decontamination Records Archive

Date	Document Type	Archived By	Location
07/02/2025	Decontamination Logs	Sunita Sharma	Archive Room A

Annexure-11: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
08/02/2025	Decontamination Procedures	EHS Manager	Ravi Kumar

Annexure-12: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
09/02/2025	Decontamination Compliance Audit	No Major Issues Found	N/A	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 Decontamination Procedures and Documentation Formats	Regulatory Compliance	QA Head