SOP for Environmental Monitoring of Raw Material Warehouse – V 2.0
Standard Operating Procedure for Environmental Monitoring of Raw Material Warehouse
| Department |
Warehouse / Quality Assurance |
| SOP No. |
SOP/RM/119/2025 |
| Supersedes |
SOP/RM/119/2022 |
| Page No. |
Page 1 of 15 |
| Issue Date |
19/02/2025 |
| Effective Date |
23/02/2025 |
| Review Date |
19/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) defines the process for environmental monitoring in raw material warehouses to ensure compliance with Good Manufacturing Practices (GMP) and to maintain the quality of stored materials.
2. Scope
This SOP applies to all environmental monitoring activities, including temperature, humidity, particulate matter, and microbial contamination, within the raw material storage areas.
3. Responsibilities
- Warehouse Personnel: Perform routine environmental monitoring and report deviations.
- Quality Assurance (QA): Review and verify monitoring data, conduct audits, and ensure compliance with regulatory requirements.
- Warehouse Manager: Ensure monitoring equipment is functional and staff are trained on monitoring procedures.
4. Accountability
The Warehouse Manager is accountable for the implementation of environmental monitoring protocols, while the QA Manager ensures that all monitoring data meets GMP standards.
5. Procedure
5.1 Environmental Monitoring Parameters
- Temperature Monitoring:
- Measure and record warehouse temperature twice daily using calibrated thermometers or automated data loggers.
- Acceptable temperature range: 15°C to 25°C unless specified otherwise for specific raw materials.
- Document readings in the Temperature Monitoring Log (Annexure-1).
- Humidity Monitoring:
- Monitor and record relative humidity (RH) levels twice daily using hygrometers or automated systems.
- Acceptable humidity range: 30% to 60% RH, with stricter controls for moisture-sensitive materials.
- Document readings in the Humidity Monitoring Log (Annexure-2).
- Particulate Monitoring:
- Conduct particulate monitoring monthly using calibrated particle counters in designated areas.
- Ensure levels are within acceptable limits as per ISO Class standards.
- Document results in the Particulate Monitoring Log (Annexure-3).
- Microbial Monitoring:
- Perform microbial monitoring monthly using settle plates, contact plates, and air samplers.
- Collect samples from high-touch surfaces, air vents, and other critical areas.
- Document results in the Microbial Monitoring Log (Annexure-4).
5.2 Equipment Calibration and Maintenance
- Calibration of Monitoring Devices:
- Ensure all monitoring equipment (thermometers, hygrometers, particle counters) is calibrated quarterly by certified personnel.
- Maintain calibration certificates and document calibration activities in the Equipment Calibration Log (Annexure-5).
- Routine Equipment Maintenance:
- Inspect monitoring equipment weekly for damage or malfunction.
- Replace batteries, clean sensors, and ensure proper functioning of automated systems.
- Document maintenance activities in the Equipment Maintenance Log (Annexure-6).
5.3 Handling of Deviations
- Identification of Deviations:
- Identify deviations when environmental conditions fall outside the acceptable range.
- Immediately report deviations to the Warehouse Manager and QA for corrective action.
- Document deviations in the Environmental Monitoring Deviation Log (Annexure-7).
- Corrective and Preventive Actions (CAPA):
- Investigate the root cause of deviations and implement corrective actions such as adjusting HVAC settings or relocating sensitive materials.
- Document corrective and preventive actions in the CAPA Log (Annexure-8).
5.4 Review and Verification of Monitoring Data
- Daily Review:
- Warehouse Supervisors review temperature and humidity logs daily for completeness and accuracy.
- Document reviews in the Daily Monitoring Review Log (Annexure-9).
- QA Verification:
- QA conducts monthly reviews of all environmental monitoring data to ensure compliance with GMP standards.
- Document verification in the QA Verification Log (Annexure-10).
5.5 Periodic Audits and Reporting
- Internal Audits:
- QA conducts quarterly audits of environmental monitoring processes to identify gaps and areas for improvement.
- Document audit findings in the Environmental Monitoring Audit Log (Annexure-11).
- Reporting:
- Prepare quarterly environmental monitoring reports summarizing findings, deviations, and corrective actions.
- Submit reports to senior management for review.
- Document reports in the Environmental Monitoring Report Log (Annexure-12).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- RH: Relative Humidity
- CAPA: Corrective and Preventive Actions
7. Documents
- Temperature Monitoring Log (Annexure-1)
- Humidity Monitoring Log (Annexure-2)
- Particulate Monitoring Log (Annexure-3)
- Microbial Monitoring Log (Annexure-4)
- Equipment Calibration Log (Annexure-5)
- Equipment Maintenance Log (Annexure-6)
- Environmental Monitoring Deviation Log (Annexure-7)
- CAPA Log (Annexure-8)
- Daily Monitoring Review Log (Annexure-9)
- QA Verification Log (Annexure-10)
- Environmental Monitoring Audit Log (Annexure-11)
- Environmental Monitoring Report Log (Annexure-12)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ISO 14644 – Cleanrooms and Associated Controlled Environments
- WHO GMP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
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Approved By |
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11. Annexures
Annexure-1: Temperature Monitoring Log
| Date |
Time |
Temperature (°C) |
Recorded By |
| 19/02/2025 |
08:00 AM |
22°C |
Ravi Kumar |
Annexure-2: Humidity Monitoring Log
| Date |
Time |
Humidity (%) |
Recorded By |
| 19/02/2025 |
08:00 AM |
45% |
Sunita Sharma |
Annexure-3: Particulate Monitoring Log
| Date |
Area Monitored |
Particle Count (per m³) |
Recorded By |
| 01/02/2025 |
Storage Room A |
1,000 |
Anjali Mehta |
Annexure-4: Microbial Monitoring Log
| Date |
Sample Type |
CFU Count |
Recorded By |
| 01/02/2025 |
Settle Plate |
3 CFU |
Ravi Kumar |
Annexure-5: Equipment Calibration Log
| Date |
Equipment |
Calibration Status |
Performed By |
| 01/01/2025 |
Thermometer |
Calibrated |
Sunita Sharma |
Annexure-6: Equipment Maintenance Log
| Date |
Equipment |
Maintenance Performed |
Performed By |
| 15/02/2025 |
Hygrometer |
Battery Replacement |
Ravi Kumar |
Annexure-7: Environmental Monitoring Deviation Log
| Date |
Deviation |
Action Taken |
Reported By |
| 10/02/2025 |
High Humidity (65%) |
Adjusted Dehumidifier |
Anjali Mehta |
Annexure-8: CAPA Log
| Date |
Issue |
Corrective Action |
Performed By |
| 11/02/2025 |
Temperature Fluctuation |
Calibrated HVAC System |
Ravi Kumar |
Annexure-9: Daily Monitoring Review Log
| Date |
Reviewed By |
Findings |
Corrective Actions |
| 19/02/2025 |
Sunita Sharma |
All Parameters Within Range |
N/A |
Annexure-10: QA Verification Log
| Date |
Verified By |
Findings |
Corrective Actions |
| 01/02/2025 |
Anjali Mehta |
Compliant |
N/A |
Annexure-11: Environmental Monitoring Audit Log
| Date |
Audit Type |
Findings |
Corrective Actions |
Audited By |
| 01/01/2025 |
Quarterly Environmental Audit |
All Procedures Compliant |
N/A |
QA Head |
Annexure-12: Environmental Monitoring Report Log
| Date |
Report Period |
Findings Summary |
Prepared By |
| 01/02/2025 |
Q1 2025 |
No Deviations Detected |
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 |
| 01/02/2025 |
2.0 |
Updated GMP Compliance Procedures |
Regulatory Compliance |
QA Head |