Standard Operating Procedure for Environmental Monitoring in 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) outlines the methods for environmental monitoring in raw material warehouses to ensure compliance with Good Manufacturing Practices (GMP) and maintain the integrity of stored materials.
2. Scope
This SOP applies to the monitoring of temperature, humidity, particulate matter, and microbial contamination in all raw material storage areas within the warehouse.
3. Responsibilities
- Warehouse Personnel: Conduct routine environmental monitoring and report deviations.
- Quality Assurance (QA): Review monitoring data, verify compliance with regulatory standards, and conduct periodic audits.
- Warehouse Manager: Ensure monitoring equipment is functional and properly calibrated, and staff are trained on monitoring procedures.
4. Accountability
The Warehouse Manager is accountable for the execution of environmental monitoring procedures, while the QA Manager is responsible for ensuring data integrity and regulatory compliance.
5. Procedure
5.1 Environmental Monitoring Parameters
- Temperature Monitoring:
- Measure warehouse temperature twice daily using calibrated thermometers or automated data loggers.
- Maintain temperatures between 15°C to
25°C unless specified otherwise for specific raw materials.
Record data in the Temperature Monitoring Log (Annexure-1).
Humidity Monitoring:
Particulate Monitoring:
Microbial Monitoring:
- Record relative humidity (RH) levels twice daily using hygrometers.
- Acceptable humidity range is 30% to 60% RH.
- Document readings in the Humidity Monitoring Log (Annexure-2).
- Conduct monthly monitoring using particle counters in designated areas.
- Ensure particulate levels are within ISO Class limits.
- Record data in the Particulate Monitoring Log (Annexure-3).
- Perform monthly microbial testing using settle plates, air samplers, and contact plates.
- Sample high-touch surfaces, air vents, and storage areas.
- Document results in the Microbial Monitoring Log (Annexure-4).
5.2 Calibration and Maintenance of Monitoring Equipment
- Calibration:
- Calibrate all monitoring devices (thermometers, hygrometers, particle counters) quarterly by certified personnel.
- Maintain calibration certificates and record details in the Calibration Log (Annexure-5).
- Maintenance:
- Inspect monitoring devices weekly for proper functioning.
- Replace batteries, clean sensors, and repair equipment as necessary.
- Document maintenance activities in the Maintenance Log (Annexure-6).
5.3 Handling Deviations
- Deviation Identification:
- Identify deviations when environmental conditions exceed acceptable limits.
- Report deviations immediately to the Warehouse Manager and QA.
- Document deviations in the Deviation Log (Annexure-7).
- Corrective Actions:
- Investigate the root cause and implement corrective actions such as adjusting HVAC settings or relocating materials.
- Document corrective actions in the CAPA Log (Annexure-8).
5.4 Data Review and Reporting
- Daily Review:
- Warehouse Supervisors review daily monitoring logs for completeness and accuracy.
- Record reviews in the Daily Review Log (Annexure-9).
- Monthly QA Verification:
- QA verifies environmental monitoring data monthly to ensure compliance with GMP.
- Document verification in the QA Verification Log (Annexure-10).
5.5 Periodic Audits
- Internal Audits:
- QA conducts quarterly audits of the environmental monitoring process.
- Document audit findings in the Audit Log (Annexure-11).
- Reporting:
- Prepare quarterly reports summarizing monitoring data, deviations, and corrective actions.
- Submit reports to senior management and maintain records in the Reporting Log (Annexure-12).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- RH: Relative Humidity
- CAPA: Corrective and Preventive Action
7. Documents
- Temperature Monitoring Log (Annexure-1)
- Humidity Monitoring Log (Annexure-2)
- Particulate Monitoring Log (Annexure-3)
- Microbial Monitoring Log (Annexure-4)
- Calibration Log (Annexure-5)
- Maintenance Log (Annexure-6)
- Deviation Log (Annexure-7)
- CAPA Log (Annexure-8)
- Daily Review Log (Annexure-9)
- QA Verification Log (Annexure-10)
- Audit Log (Annexure-11)
- Reporting 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
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
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 Area A | 1,000 | Anjali Mehta |
Annexure-4: Microbial Monitoring Log
| Date | Sample Type | CFU Count | Recorded By |
|---|---|---|---|
| 01/02/2025 | Air Sampler | 3 CFU | Ravi Kumar |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 19/02/2025 | 2.0 | Updated Environmental Monitoring Procedures | Regulatory Compliance | QA Head |