Standard Operating Procedure for Handling Biodegradable and Environmentally Sensitive Raw Materials in Quarantine
Department | Quality Assurance / Warehouse / Environmental Health & Safety |
---|---|
SOP No. | SOP/RM/093/2025 |
Supersedes | SOP/RM/093/2022 |
Page No. | Page 1 of 15 |
Issue Date | 01/02/2025 |
Effective Date | 05/02/2025 |
Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) describes the methods and practices for handling biodegradable and environmentally sensitive raw materials in quarantine. The procedure ensures proper storage, handling, and disposal of such materials while complying with Good Manufacturing Practices (GMP) and environmental regulations.
2. Scope
This SOP applies to all biodegradable and environmentally sensitive raw materials, including organic solvents, biodegradable excipients, and plant-based APIs, stored in quarantine at the facility. It includes procedures for storage, monitoring, and safe handling to prevent contamination and environmental hazards.
3. Responsibilities
- Warehouse Personnel: Ensure proper storage conditions, labeling, and handling of biodegradable and sensitive materials in quarantine.
- Quality Control (QC): Conduct regular checks and tests to ensure the integrity of materials and compliance with environmental guidelines.
- Quality Assurance (QA): Oversee the handling process and ensure compliance with regulatory and company-specific guidelines.
- Environmental Health & Safety (EHS): Ensure compliance with environmental regulations and provide
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
- 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).
- Documentation:
- Document all identified materials in the Biodegradable Material Register (Annexure-1).
5.2 Storage of Biodegradable and Environmentally Sensitive Materials
- 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).
- 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
- 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.
- Clearly label all containers with:
- 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
- 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).
- 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
- 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).
- 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
- 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).
- 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
- Biodegradable Material Register (Annexure-1)
- Environmental Monitoring Log (Annexure-2)
- Deviation Log (Annexure-3)
- Spill Response Plan (Annexure-4)
- Biodegradable Material Disposal Log (Annexure-5)
- Biodegradable Material Handling Log (Annexure-6)
- Compliance Audit Log (Annexure-7)
- 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 |