Procedure for Managing Retained Samples of Aerosol Products
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/200/2025 |
| Supersedes | SOP/Aerosol/200/2022 |
| 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 define a systematic approach for the storage, monitoring, and disposal of retained samples of aerosol products to ensure product quality, traceability, and regulatory compliance.
2. Scope
This SOP applies to all retained samples of finished aerosol products stored in the Quality Control (QC) laboratory or designated retention areas.
3. Responsibilities
- Quality Control (QC) Analysts: Responsible for managing retained samples as per storage conditions.
- Quality Assurance (QA) Team: Responsible for periodic review and audit of retained sample inventory.
- Warehouse Team: Responsible for maintaining proper storage conditions.
- Regulatory Affairs Team: Responsible for compliance with regulatory requirements.
4. Accountability
The Quality Control Manager is accountable for ensuring proper retention, monitoring, and disposal of retained samples as per regulatory guidelines.
5. Procedure
5.1. Sample Selection and Retention Criteria
- Select representative retained samples from each production batch.
- Ensure retained samples include different packaging configurations.
- Record sample details in the Retained Sample Log (Annexure-1).
5.2. Storage Conditions
- Store retained samples under controlled conditions (e.g., 25°C/60% RH).
- Maintain segregation of retained samples from active production stock.
- Record storage conditions in the Retained Sample Storage Log (Annexure-2).
5.3. Periodic Review
and Monitoring
- Conduct periodic checks on retained sample integrity.
- Monitor for changes in physical appearance, pressure loss, or leakage.
- Record findings in the Retained Sample Monitoring Log (Annexure-3).
5.4. Disposal of Retained Samples
- Dispose of retained samples after the retention period (as per regulatory guidelines).
- Ensure safe disposal by following environmental and safety protocols.
- Record sample disposal details in the Retained Sample Disposal Log (Annexure-4).
5.5. Corrective Actions for Sample Deviations
- Investigate any observed physical or chemical changes in retained samples.
- Take corrective actions such as batch recall or reformulation.
- Record corrective actions in the Retained Sample Corrective Action Log (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- RH: Relative Humidity
- SOP: Standard Operating Procedure
7. Documents
- Retained Sample Log (Annexure-1)
- Retained Sample Storage Log (Annexure-2)
- Retained Sample Monitoring Log (Annexure-3)
- Retained Sample Disposal Log (Annexure-4)
- Retained Sample Corrective Action Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ICH Q1A Stability Testing Guidelines
- FDA Guidance on Sample Retention
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Retained Sample Log
| Batch No. | Sample ID | Storage Condition | Checked By |
|---|---|---|---|
| BN-270 | SPL-601 | 25°C/60% RH | QA Team |
Annexure-2: Retained Sample Storage Log
| Sample ID | Storage Location | Temperature (°C) | Reviewed By |
|---|---|---|---|
| SPL-601 | Retention Area 1 | 25°C | QA Team |
Annexure-3: Retained Sample Monitoring Log
| Sample ID | Inspection Date | Observations | Reviewed By |
|---|---|---|---|
| SPL-601 | 07/02/2025 | No Change | QA Team |
Annexure-4: Retained Sample Disposal Log
| Sample ID | Disposal Date | Disposal Method | Approved By |
|---|---|---|---|
| SPL-601 | 08/02/2027 | Incineration | QA Team |
Annexure-5: Retained Sample Corrective Action Log
| Issue Identified | Corrective Action | Implementation Date | Approved By |
|---|---|---|---|
| Physical Change Observed | Batch Recall | 08/02/2025 | Anjali Sharma |
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 retention guidelines | GMP Compliance | Anjali Sharma |