SOP for Handling and Disposal of Expired Raw Materials
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/007/2025 |
| Supersedes | SOP/Aerosol/007/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for handling and disposing of expired raw materials used in aerosol manufacturing. It ensures that expired materials are properly segregated, documented, and disposed of in compliance with Good Manufacturing Practices (GMP) and regulatory requirements to prevent contamination or misuse.
2. Scope
This procedure applies to all personnel involved in the handling, segregation, and disposal of expired raw materials in aerosol manufacturing at [Company Name]. It covers the identification, storage, and proper disposal of expired materials to ensure safety and compliance. This SOP does not apply to materials in the production process or finished products.
3. Responsibilities
- Warehouse Supervisor: Responsible for ensuring that expired raw materials are properly segregated, stored, and disposed of according to this SOP.
- Quality Control (QC) Team: Responsible for verifying the expiration status of materials and ensuring proper documentation of expired materials.
- Production Personnel: Responsible for notifying the Warehouse Supervisor and QC team if expired materials are discovered during production.
- Disposal Personnel: Responsible for the safe disposal of expired materials and ensuring that the disposal process complies with environmental and safety regulations.
4. Accountability
The Warehouse Manager is accountable for ensuring that this SOP is followed during the handling and disposal of expired raw materials and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.
5. Procedure
5.1. Identification of Expired Raw Materials
- Expired raw materials should be identified based on their expiration date, which must be clearly marked on the packaging by the supplier or as per company standards.
- Regular checks should be conducted on raw materials to identify those that are approaching their expiry date. These materials should be segregated and placed in a designated quarantine area until verification.
- If materials are discovered past their expiry date, they must be immediately removed from the storage area and isolated for proper disposal.
5.2. Segregation and Documentation of Expired Materials
- Expired materials should be clearly labeled as “Expired” and segregated from usable materials in a designated area to prevent accidental use.
- All expired raw materials must be logged in the Expired Materials Log (Annexure-1) with details including material name, batch number, expiry date, quantity, and the date they were removed from storage.
- A report of expired materials should be submitted to the Quality Control (QC) team for verification before disposal.
5.3. Disposal of Expired Raw Materials
- Expired raw materials must be disposed of according to company policies and local environmental regulations. Materials may be returned to the supplier, recycled, or discarded, depending on their nature.
- The disposal method must ensure that the expired materials do not pose a risk to health, safety, or the environment. Disposal activities should be carried out by authorized personnel only.
- All disposal activities must be documented in the Material Disposal Log (Annexure-2) and include details of the material disposed of, the quantity, the disposal method, and the personnel involved.
5.4. Corrective and Preventive Actions (CAPA)
- If expired materials are found to have been used in production, immediate corrective actions must be taken to assess the impact on the final product. The affected batch should be quarantined, and a full investigation should be conducted.
- Preventive actions should be taken to reduce the risk of expired materials being used in the future, such as improving labeling systems, implementing more frequent inventory checks, and reviewing expiry date tracking processes.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- CAPA: Corrective and Preventive Actions
7. Documents
- Expired Materials Log (Annexure-1)
- Material Disposal Log (Annexure-2)
- Disposal Authorization Form (Annexure-3)
8. References
This SOP is based on the following regulatory guidelines and industry standards:
- Good Manufacturing Practice (GMP) Guidelines
- FDA Code of Federal Regulations (CFR) Title 21, Part 211
- ISO 9001:2015 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Expired Materials Log
| Material Name | Batch No. | Expiry Date | Quantity | Segregation Date |
|---|---|---|---|---|
| Example Material | 12345 | 01/01/2025 | 50 kg | 06/02/2025 |
Annexure-2: Material Disposal Log
| Material Name | Batch No. | Quantity Disposed | Disposal Date | Disposal Method | Disposed By |
|---|---|---|---|---|---|
| Example Material | 12345 | 50 kg | 06/02/2025 | Incineration | Ravi Kumar |
Annexure-3: Disposal Authorization Form
| Material Name | Batch No. | Quantity | Disposal Method | Authorized By | Disposal Date |
|---|---|---|---|---|---|
| Example Material | 12345 | 50 kg | Incineration | Rajesh Patel | 06/02/2025 |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma | Page 1 | [Ref Point] | First Release |
| 01/01/2025 | V 2.0 | Updated disposal methods and added corrective actions | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |