Standard Operating Procedure for Checking Material Expiry Dates during Dispensing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/013/2025 |
| Supersedes | SOP/CRM/013/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 30/04/2025 |
| Effective Date | 05/05/2025 |
| Review Date | 30/04/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to ensure that all materials used during the dispensing process are checked for their expiry dates. This helps to prevent the use of expired materials in cream formulations, ensuring product quality, safety, and compliance with regulatory requirements.
2. Scope
This SOP applies to all materials used in the dispensing process within the Creams Department, including raw materials, excipients, and active ingredients. It covers the procedures for checking expiry dates and handling expired materials.
3. Responsibilities
- Production Personnel: Responsible for checking the expiry dates of all materials before dispensing, ensuring that no expired materials are used in the formulation process.
- Quality Control (QC): Verifies that the expiry dates of materials have been checked and ensures that expired materials are removed from the dispensing area.
- Quality Assurance (QA): Ensures compliance with this SOP and investigates any discrepancies related to the use of expired materials.
- Warehouse Personnel: Responsible for ensuring that materials with valid expiry dates are provided for dispensing and that expired materials are segregated and removed from storage.
4. Accountability
The Head of Creams Manufacturing is responsible for ensuring that the material expiry date checking process is implemented correctly. The QA Manager is ultimately responsible for overseeing compliance with this SOP and investigating any use of expired materials.
5. Procedure
5.1 Pre-Dispensing Preparation
- Before dispensing any material, verify that the material inventory is up to date and that no expired materials are present in the dispensing area.
- Ensure that all materials are properly labeled with their expiry dates. If the expiry date is not clearly visible or if there is any doubt about its validity, the material should not be used and should be flagged for review by QA.
- Any materials that have an expiry date within the next 30 days or past their expiry date should be segregated and clearly marked as expired.
- Ensure that materials with short shelf lives or nearing expiration are used first, in accordance with the First Expired, First Out (FEFO) system.
5.2 Checking Expiry Dates During Dispensing
- Before dispensing any material, production personnel must verify the expiry date of each material. This can be done by reviewing the material packaging or label.
- If any material has an expired date, it should not be used in production and should be reported to QA immediately for investigation.
- If materials are close to expiry (within the next 30 days), note this information in the Material Dispensing Log and ensure that they are used in the current batch if possible. If the material is not required for the current batch, return it to the appropriate storage area or segregate it for later use.
5.3 Handling Expired Materials
- Any expired materials should be removed immediately from the dispensing area to prevent their accidental use in production.
- Expired materials should be clearly labeled and segregated in a designated area for disposal or return to the warehouse, as per the company’s material disposal procedures.
- If expired materials are found in the dispensing area, they should be reported immediately to the QA team, and the batch process should be paused until the issue is resolved.
5.4 Documentation During Dispensing
- All materials dispensed should be recorded in the Material Dispensing Log, including the expiry date of the material. Any expired materials should be noted in the Material Transfer Log or a specific Discrepancy Report.
- Any discrepancies found in the expiry date during the dispensing process must be documented in the Material Discrepancy Report, including the material name, batch number, and the reason for the discrepancy.
- The Material Dispensing Log and any related reports must be reviewed and signed by both the production personnel and the QA team for approval.
5.5 Corrective Actions for Expired Material Usage
- If expired material is accidentally used, the batch should be placed on hold immediately, and the material should be discarded or quarantined as per the company’s protocols.
- The cause of the issue should be investigated, and corrective actions should be taken to prevent future occurrences. This may include retraining of personnel or improvement of inventory management systems.
- A Corrective Action Report should be completed and reviewed by the QA team, documenting the cause of the incident, corrective actions taken, and preventive measures implemented.
5.6 Final Review and Approval
- The QA team will review the Material Dispensing Log and any related discrepancy reports to ensure that all expired materials have been handled appropriately and that no expired materials were used in production.
- Once all materials have been verified, the batch can be approved for further processing, or corrective actions may be implemented if expired materials were used.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- FEFO: First Expired, First Out
7. Documents
- Material Dispensing Log (Annexure-1)
- Material Discrepancy Report (Annexure-2)
- Corrective Action Report (Annexure-3)
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- Internal SOP for Material Handling and Dispensing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Material Dispensing Log
| Material Name | Batch Number | Quantity Dispensed | Expiry Date | Dispensed By | Time/Date |
|---|---|---|---|---|---|
| Material A | 12345 | 500g | 10/05/2025 | John Doe | 30/04/2025 |
Annexure-2: Material Discrepancy Report
| Material Name | Batch Number | Discrepancy Description | Corrective Action Taken | Reported By | Resolution Date |
|---|---|---|---|---|---|
| Material B | 67890 | Expired material used | Discarded batch, retrained personnel | John Doe | 30/04/2025 |
Annexure-3: Corrective Action Report
| Deviation | Corrective Action Taken | Responsible Person | Completion Date |
|---|---|---|---|
| Expired Material Usage | Reviewed material tracking system, retrained personnel | John Doe | 02/05/2025 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |