Standard Operating Procedure for Documentation of Raw Material Storage Conditions
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/115/2025 |
| Supersedes | SOP/RM/115/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 15/02/2025 |
| Effective Date | 19/02/2025 |
| Review Date | 15/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the methodology for accurate documentation of raw material storage conditions, ensuring compliance with Good Manufacturing Practices (GMP) and safeguarding material integrity.
2. Scope
This SOP applies to the documentation of storage conditions, including temperature, humidity, and special handling requirements, for all raw materials stored in the warehouse.
3. Responsibilities
- Warehouse Personnel: Accurately record storage conditions daily and report any deviations promptly.
- Quality Assurance (QA): Review and verify documentation accuracy and ensure compliance with GMP standards.
- Warehouse Manager: Ensure proper implementation of this SOP and provide training on documentation protocols.
4. Accountability
The Warehouse Manager is accountable for ensuring accurate and timely documentation, while the QA Manager is responsible for verifying the records for compliance with regulatory requirements.
5. Procedure
5.1 Identification of Storage Conditions
- Material Classification:
- Identify and classify raw materials based on their storage requirements (e.g., temperature-sensitive, humidity-sensitive).
- Label storage areas accordingly
to reflect specific material needs.
Document material classifications in the Material Classification Log (Annexure-1).
Storage Requirements:
- Refer to the supplier’s Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) for storage guidelines.
- Document specific storage requirements in the Storage Requirement Log (Annexure-2).
5.2 Documentation of Temperature and Humidity
- Daily Monitoring:
- Record temperature and humidity levels twice daily (start and end of shift) using calibrated devices.
- For temperature-sensitive materials, use automated data loggers for continuous monitoring.
- Document readings in the Temperature and Humidity Log (Annexure-3).
- Acceptable Ranges:
- Maintain temperature between 15°C and 25°C, unless otherwise specified.
- Keep humidity between 30% and 60%, with tighter controls for sensitive materials.
5.3 Documentation of Special Handling Conditions
- Cold Chain Materials:
- Document storage in refrigerated units (2°C to 8°C) for cold chain materials.
- Use dedicated Cold Chain Storage Logs to track storage and transport conditions (Annexure-4).
- Hazardous Materials:
- Document storage of hazardous materials in explosion-proof cabinets or isolated areas.
- Track the use of Personal Protective Equipment (PPE) and safety protocols in the Hazardous Material Handling Log (Annexure-5).
5.4 Review and Verification of Documentation
- Daily Review:
- Warehouse Supervisors review documentation at the end of each shift to ensure completeness and accuracy.
- Document reviews in the Daily Review Log (Annexure-6).
- QA Verification:
- QA conducts weekly reviews of all storage condition records for compliance with GMP requirements.
- Document QA reviews in the QA Verification Log (Annexure-7).
5.5 Handling of Documentation Deviations
- Deviation Identification:
- Identify discrepancies or missing information in storage condition records.
- Report deviations to the Warehouse Manager and QA immediately.
- Document deviations in the Deviation Log (Annexure-8).
- Corrective Actions:
- Investigate root causes and implement corrective actions to prevent recurrence.
- Document corrective measures in the Corrective Action Log (Annexure-9).
5.6 Periodic Review and Compliance Monitoring
- Monthly Data Review:
- Compile and review storage condition data monthly for trends and recurring deviations.
- Prepare summary reports and submit to QA for evaluation.
- Document reviews in the Monthly Data Review Log (Annexure-10).
- Quarterly Compliance Audits:
- QA will conduct quarterly audits of storage documentation to ensure regulatory compliance.
- Document audit findings in the Compliance Audit Log (Annexure-11).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- MSDS: Material Safety Data Sheet
- COA: Certificate of Analysis
- PPE: Personal Protective Equipment
7. Documents
- Material Classification Log (Annexure-1)
- Storage Requirement Log (Annexure-2)
- Temperature and Humidity Log (Annexure-3)
- Cold Chain Storage Log (Annexure-4)
- Hazardous Material Handling Log (Annexure-5)
- Daily Review Log (Annexure-6)
- QA Verification Log (Annexure-7)
- Deviation Log (Annexure-8)
- Corrective Action Log (Annexure-9)
- Monthly Data Review Log (Annexure-10)
- Compliance Audit Log (Annexure-11)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO GMP Guidelines
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 Classification Log
| Date | Material Name | Classification | Identified By |
|---|---|---|---|
| 15/02/2025 | Vitamin C | Humidity-Sensitive | Ravi Kumar |
Annexure-2: Storage Requirement Log
| Date | Material Name | Storage Condition | Documented By |
|---|---|---|---|
| 15/02/2025 | Vitamin C | 15°C to 25°C, < 50% RH | Sunita Sharma |
Annexure-3: Temperature and Humidity Log
| Date | Time | Temperature (°C) | Humidity (%) | Recorded By |
|---|---|---|---|---|
| 15/02/2025 | 08:00 AM | 22°C | 45% | Sunita Sharma |
Annexure-4: Cold Chain Storage Log
| Date | Material Name | Storage Temperature (°C) | Checked By |
|---|---|---|---|
| 15/02/2025 | Insulin | 4°C | Ravi Kumar |
Annexure-5: Hazardous Material Handling Log
| Date | Material Name | Storage Area | PPE Used | Handled By |
|---|---|---|---|---|
| 15/02/2025 | Acetone | Explosion-Proof Cabinet 1 | Gloves, Goggles | Anjali Mehta |
Annexure-6: Daily Review Log
| Date | Reviewed By | Findings | Corrective Actions |
|---|---|---|---|
| 15/02/2025 | Ravi Kumar | All records complete | N/A |
Annexure-7: QA Verification Log
| Date | Verified By | Findings | Corrective Actions |
|---|---|---|---|
| 15/02/2025 | Anjali Mehta | Compliant | N/A |
Annexure-8: Deviation Log
| Date | Deviation | Action Taken | Reported By |
|---|---|---|---|
| 14/02/2025 | Missing temperature reading | Re-recorded and documented | Sunita Sharma |
Annexure-9: Corrective Action Log
| Date | Issue | Corrective Action | Performed By |
|---|---|---|---|
| 14/02/2025 | Humidity deviation | Adjusted dehumidifier settings | Ravi Kumar |
Annexure-10: Monthly Data Review Log
| Date | Reviewed By | Findings | Corrective Actions |
|---|---|---|---|
| 15/02/2025 | Anjali Mehta | No deviations found | N/A |
Annexure-11: Compliance Audit Log
| Date | Audit Type | Findings | Corrective Actions | Audited By |
|---|---|---|---|---|
| 15/02/2025 | Storage Documentation Audit | Compliant | N/A | Anjali Mehta |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 15/02/2025 | 2.0 | Updated Documentation Procedures | Regulatory Compliance | QA Head |