training on safe handling procedures.

4. Accountability

The QA Manager is accountable for ensuring compliance with regulatory standards for handling biodegradable and environmentally sensitive materials. The EHS Manager is responsible for ensuring environmental regulations are followed during storage and handling processes.

5. Procedure

5.1 Identification and Documentation of Biodegradable Materials

1. Material Identification:
   • All biodegradable and environmentally sensitive materials must be clearly identified upon receipt.
   • QC will categorize materials as biodegradable or environmentally sensitive based on Material Safety Data Sheets (MSDS).
2. Documentation:
   • Document all identified materials in the Biodegradable Material Register (Annexure-1).

5.2 Storage of Biodegradable and Environmentally Sensitive Materials

1. Storage Conditions:
   • Store biodegradable materials in a designated area within the quarantine zone, separate from non-biodegradable materials.
   • Maintain appropriate temperature and humidity conditions to prevent degradation.
   • Ensure proper ventilation in storage areas for materials that emit volatile organic compounds (VOCs).
2. Environmental Monitoring:
   • Monitor storage conditions regularly and record in the Environmental Monitoring Log (Annexure-2).
   • Address any deviations in environmental conditions promptly and document corrective actions in the Deviation Log (Annexure-3).

5.3 Handling and Movement of Biodegradable Materials

1. Labeling Requirements:
   • Clearly label all containers with:
     • Material Name
     • Batch/Lot Number
     • Storage Conditions
     • “Biodegradable” or “Environmentally Sensitive” status
   • Use green-colored tags for biodegradable materials and blue-colored tags for environmentally sensitive materials.
2. Movement within Quarantine:
   • Use designated pathways for moving biodegradable materials to prevent cross-contamination.
   • Ensure proper sealing of containers before any movement within the facility.

5.4 Handling Spills and Contamination

1. Immediate Response:
   • In case of spills, immediately isolate the area and notify the EHS department.
   • Use appropriate spill containment materials and follow procedures outlined in the Spill Response Plan (Annexure-4).
2. Disposal of Contaminated Materials:
   • Contaminated biodegradable materials must be disposed of following environmental regulations.
   • Document all disposal activities in the Biodegradable Material Disposal Log (Annexure-5).

5.5 Documentation and Record-Keeping

1. Material Handling Records:
   • Maintain detailed records of all biodegradable materials, including storage conditions, movement logs, and disposal activities.
   • Record all entries in the Biodegradable Material Handling Log (Annexure-6).
2. Compliance Audits:
   • QA and EHS conduct periodic audits of the storage and handling processes.
   • Document audit findings in the Compliance Audit Log (Annexure-7).

5.6 Training and Compliance Monitoring

1. Personnel Training:
   • All personnel involved in handling biodegradable and environmentally sensitive materials must undergo specialized training.
   • Document training sessions in the Training Log (Annexure-8).
2. Monitoring and Review:
   • Regularly review procedures and update them in accordance with new regulations and environmental guidelines.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• EHS: Environmental Health & Safety
• MSDS: Material Safety Data Sheet
• VOCs: Volatile Organic Compounds

7. Documents

1. Biodegradable Material Register (Annexure-1)
2. Environmental Monitoring Log (Annexure-2)
3. Deviation Log (Annexure-3)
4. Spill Response Plan (Annexure-4)
5. Biodegradable Material Disposal Log (Annexure-5)
6. Biodegradable Material Handling Log (Annexure-6)
7. Compliance Audit Log (Annexure-7)
8. Training Log (Annexure-8)

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 Environmentally Sensitive 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: Biodegradable Material Register

Date	Material Name	Batch Number	Category	Registered By
01/02/2025	Plant-Based API-X	API-X-2025-001	Biodegradable	Sunita Sharma

Annexure-2: Environmental Monitoring Log

Date	Time	Temperature (°C)	Humidity (%)	Recorded By
01/02/2025	09:00 AM	22°C	40%	Ravi Kumar

Annexure-3: Deviation Log

Date	Material Name	Batch Number	Deviation Description	Corrective Action
02/02/2025	Plant-Based API-X	API-X-2025-001	Temperature Spike to 28°C	Adjusted HVAC System

Annexure-4: Spill Response Plan

Date	Material Name	Batch Number	Spill Description	Response Actions
03/02/2025	Solvent-Y	SLV-Y-2025-002	Minor Solvent Leak Detected	Contained Spill, Cleaned Area, Notified EHS

Annexure-5: Biodegradable Material Disposal Log

Date	Material Name	Batch Number	Disposed By	Verified By (QA)
04/02/2025	Plant-Based API-X	API-X-2025-001	Disposal Team	Anjali Mehta

Annexure-6: Biodegradable Material Handling Log

Date	Material Name	Batch Number	Handled By	Remarks
01/02/2025	Plant-Based API-X	API-X-2025-001	Ravi Kumar	Stored under proper conditions

Annexure-7: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
05/02/2025	Storage and Handling Compliance Audit	No Major Issues Found	N/A	Anjali Mehta

Annexure-8: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
06/02/2025	Handling Biodegradable and Environmentally Sensitive Materials	EHS Manager	Sunita Sharma

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 Handling and Storage Procedures	Regulatory Compliance	QA Head