Procedure for Tracking Expiry and Retest Dates of Raw Materials in Aerosol Manufacturing
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/182/2025 |
| Supersedes | SOP/Aerosol/182/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for managing expiry and retest dates for raw materials used in aerosol manufacturing. This ensures product quality, compliance with Good Manufacturing Practices (GMP), and prevents the use of expired materials.
2. Scope
This SOP applies to all raw materials, excipients, propellants, and active pharmaceutical ingredients (APIs) used in the aerosol manufacturing department.
3. Responsibilities
- Warehouse Team: Responsible for labeling, tracking, and segregating materials based on expiry and retest dates.
- Quality Control (QC) Team: Responsible for conducting retests as per defined schedules.
- Quality Assurance (QA) Team: Responsible for reviewing and approving raw material status.
- Production Team: Responsible for verifying raw material validity before use.
4. Accountability
The Warehouse Manager is accountable for ensuring proper material storage, segregation, and adherence to retest schedules.
5. Procedure
5.1. Labeling and Storage of Raw Materials
- All raw materials must be labeled with:
- Material Name
- Batch Number
- Manufacturing Date
- Expiry Date
- Retest Date (if applicable)
- Store materials in designated temperature-controlled areas.
- Record all material details in the Raw Material Inventory Log (Annexure-1).
5.2. Tracking Expiry and Retest Dates
- Maintain
a tracking system for all raw materials.
Generate monthly reports of materials approaching expiry or retest dates.
Record tracking details in the Expiry and Retest Date Log (Annexure-2).
5.3. Retesting of Raw Materials
- Raw materials nearing their retest date must be sampled for quality testing.
- Conduct retesting as per predefined analytical methods.
- Update results in the Retest Analysis Report (Annexure-3).
- QA will review and approve retested materials before further use.
5.4. Handling Expired Materials
- Immediately segregate expired raw materials in a designated quarantine area.
- Label expired materials with “Do Not Use” tags.
- Document expired materials in the Expired Material Log (Annexure-4).
- Dispose of expired materials as per environmental safety guidelines.
5.5. Monthly Review and Compliance Monitoring
- Conduct monthly audits to verify compliance with expiry and retest date management.
- Identify trends in material expiry and take corrective actions.
- Document findings in the Compliance Review Report (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- API: Active Pharmaceutical Ingredient
- SOP: Standard Operating Procedure
7. Documents
- Raw Material Inventory Log (Annexure-1)
- Expiry and Retest Date Log (Annexure-2)
- Retest Analysis Report (Annexure-3)
- Expired Material Log (Annexure-4)
- Compliance Review Report (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- FDA Raw Material Handling Requirements
- ISO 9001 – 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: Raw Material Inventory Log
| Material Name | Batch No. | Expiry Date | Retest Date |
|---|---|---|---|
| Propellant A | PR-001 | 12/2026 | 06/2025 |
Annexure-2: Expiry and Retest Date Log
| Material Name | Batch No. | Expiry Date | Days Remaining |
|---|---|---|---|
| Valve Component | VC-789 | 08/2025 | 180 |
Annexure-3: Retest Analysis Report
| Material Name | Batch No. | Test Date | Retest Result |
|---|---|---|---|
| Solvent X | SX-456 | 07/02/2025 | Pass |
Annexure-4: Expired Material Log
| Material Name | Batch No. | Expiry Date | Disposed By |
|---|---|---|---|
| Surfactant B | SB-789 | 01/2025 | Rahul Mehta |
Annexure-5: Compliance Review Report
| Review Date | Findings | Corrective Actions | Reviewed By |
|---|---|---|---|
| 10/02/2025 | Two materials nearing expiry | Scheduled for retest | QA Team |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated tracking and compliance sections | GMP Compliance | Anjali Sharma |