Standard Operating Procedure for Handling and Disposal of Quarantined Raw Materials Beyond Retention Period
| Department | Quality Assurance / Warehouse / Environmental Health & Safety (EHS) |
|---|---|
| SOP No. | SOP/RM/098/2025 |
| Supersedes | SOP/RM/098/2022 |
| 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) outlines the process for handling and disposing of quarantined raw materials that have exceeded their retention period. It ensures safe disposal, regulatory compliance, and proper documentation to maintain Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw materials stored in the quarantine area that have not been approved for use and have surpassed their designated retention period. It includes materials awaiting testing, rejected materials, and those requiring special handling.
3. Responsibilities
- Warehouse Personnel: Identify materials beyond the retention period, label them appropriately, and coordinate with QA and EHS for disposal.
- Quality Assurance (QA): Approve the disposal of expired quarantined materials, ensure proper documentation, and verify compliance with GMP standards.
- Environmental Health & Safety (EHS): Oversee the safe disposal of hazardous or environmentally sensitive materials, ensuring compliance with environmental regulations.
4. Accountability
The
QA Manager is accountable for ensuring that all materials exceeding the retention period are identified, documented, and disposed of according to GMP and regulatory requirements. The EHS Manager is responsible for ensuring environmentally safe disposal practices.
5. Procedure
5.1 Identification of Materials Beyond Retention Period
- Monitoring Retention Periods:
- Warehouse personnel must regularly review the retention dates of quarantined materials.
- Identify materials that have exceeded their retention period and record them in the Retention Monitoring Log (Annexure-1).
- Labeling of Expired Materials:
- Clearly label materials that have exceeded their retention period with an “EXPIRED – FOR DISPOSAL” tag.
- Include material name, batch number, date of expiration, and reason for disposal on the label.
5.2 Approval for Disposal
- QA Review and Authorization:
- QA will review the Retention Monitoring Log and verify that materials are beyond the retention period.
- Complete the Disposal Authorization Form (Annexure-2) and approve materials for disposal.
- Documentation of Disposal Approval:
- Record the approved materials for disposal in the Disposal Approval Log (Annexure-3).
5.3 Disposal Process
- Segregation of Materials for Disposal:
- Warehouse personnel must segregate materials approved for disposal from other quarantined materials.
- Transfer materials to the designated disposal area within the facility.
- Disposal of Non-Hazardous Materials:
- Non-hazardous materials should be disposed of according to facility waste management protocols.
- Document disposal activities in the Non-Hazardous Material Disposal Log (Annexure-4).
- Disposal of Hazardous Materials:
- Coordinate with the EHS team for the safe disposal of hazardous or environmentally sensitive materials.
- Use certified disposal vendors and retain certificates of disposal.
- Record disposal in the Hazardous Material Disposal Log (Annexure-5).
5.4 Post-Disposal Documentation
- Final Review of Disposal Records:
- QA will review all disposal records to ensure compliance with SOP and regulatory guidelines.
- File all records in the Disposal Record Archive (Annexure-6).
- Compliance Audits:
- QA and EHS will conduct periodic audits of the disposal process to ensure compliance with environmental and GMP standards.
- Document audit findings in the Disposal Compliance Audit Log (Annexure-7).
5.5 Training and Monitoring
- Personnel Training:
- All personnel involved in the disposal process must be trained on handling and disposal procedures.
- Document training in the Disposal Training Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- EHS: Environmental Health & Safety
- MSDS: Material Safety Data Sheet
7. Documents
- Retention Monitoring Log (Annexure-1)
- Disposal Authorization Form (Annexure-2)
- Disposal Approval Log (Annexure-3)
- Non-Hazardous Material Disposal Log (Annexure-4)
- Hazardous Material Disposal Log (Annexure-5)
- Disposal Record Archive (Annexure-6)
- Disposal Compliance Audit Log (Annexure-7)
- Disposal 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
- OSHA Guidelines for the Disposal of Hazardous Waste
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Retention Monitoring Log
| Date | Material Name | Batch Number | Retention Period | Identified By |
|---|---|---|---|---|
| 01/02/2025 | API-X | API-X-2024-001 | 12 Months | Ravi Kumar |
Annexure-2: Disposal Authorization Form
| Date | Material Name | Batch Number | Authorized By | Signature |
|---|---|---|---|---|
| 02/02/2025 | API-X | API-X-2024-001 | Anjali Mehta |
Annexure-3: Disposal Approval Log
| Date | Material Name | Batch Number | Approved By | Disposed By |
|---|---|---|---|---|
| 03/02/2025 | API-X | API-X-2024-001 | Anjali Mehta | Ravi Kumar |
Annexure-4: Non-Hazardous Material Disposal Log
| Date | Material Name | Batch Number | Disposal Method | Disposed By |
|---|---|---|---|---|
| 04/02/2025 | Excipent-Y | EXC-Y-2024-002 | Incineration | Warehouse Team |
Annexure-5: Hazardous Material Disposal Log
| Date | Material Name | Batch Number | Disposal Vendor | Certificate No. |
|---|---|---|---|---|
| 05/02/2025 | Solvent-Z | SLV-Z-2024-003 | Safe Waste Disposal Ltd. | SWDL-2025-0098 |
Annexure-6: Disposal Record Archive
| Date | Document Type | Archived By | Location |
|---|---|---|---|
| 06/02/2025 | Disposal Logs | Sunita Sharma | Archive Room B |
Annexure-7: Disposal Compliance Audit Log
| Date | Audit Type | Findings | Corrective Actions | Audited By |
|---|---|---|---|---|
| 07/02/2025 | Disposal Process Audit | No Issues Found | N/A | Anjali Mehta |
Annexure-8: Disposal Training Log
| Date | Training Topic | Trainer | Attendee Name | Signature |
|---|---|---|---|---|
| 08/02/2025 | Safe Disposal of Quarantined Materials | EHS Manager | Ravi Kumar |
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 Disposal Procedures and Documentation Formats | Regulatory Compliance | QA Head |