Standard Operating Procedure for Environmental Monitoring in Warehouse in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/014/2025 |
| Supersedes | SOP/API/014/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a procedure for monitoring and documenting environmental conditions such as temperature, relative humidity, pest control, and cleanliness in API warehouse areas to ensure storage conditions comply with GMP requirements and maintain product quality.
2. Scope
This SOP is applicable to all storage zones within the API manufacturing warehouse including raw material areas, cold rooms, sampling areas, and quarantine sections.
3. Responsibilities
- Warehouse Staff: Record temperature and humidity readings daily, report deviations.
- QA Officer: Review logs, inspect cleanliness, and ensure calibration of instruments.
- Pest Control Agency: Conduct pest control activities and maintain trap records.
4. Accountability
The Warehouse Manager and QA Manager are accountable for ensuring that environmental monitoring is performed as per this SOP and any deviations are addressed promptly.
5. Procedure
5.1 Temperature and Humidity Monitoring
- Install calibrated digital thermohygrometers/data loggers in:
- General storage area
- Quarantine area
- Sampling booths
- Cold rooms (if applicable)
- Record values twice daily (morning and evening) in the “Temperature & Humidity Log” (Annexure-1).
- Acceptable limits:
- Temperature: 15–25°C (unless otherwise specified)
- Relative Humidity: ≤ 60%
- Highlight and escalate any excursions to QA and initiate deviation form.
5.2 Cleanliness Monitoring
- Perform daily housekeeping activities including sweeping, mopping, and surface wiping using approved disinfectants.
- Record activities in the “Warehouse Cleaning Checklist” (Annexure-2).
- QA to inspect cleanliness weekly and sign the verification column.
5.3 Pest Control Monitoring
- Contracted pest control agency shall carry out services as per approved schedule (Annexure-3).
- Place glue traps/insectocutors at:
- Entry/Exit Points
- Storage corners
- Near drains
- Maintain “Pest Monitoring Record” (Annexure-4).
- Review and trend the pest count monthly to assess effectiveness.
5.4 Equipment Calibration
- Thermometers, hygrometers, and data loggers must be calibrated at least once every 6 months.
- Record calibration details in the “Instrument Calibration Log” (Annexure-5).
5.5 Handling Deviations
- In case of temperature/humidity deviation:
- Quarantine affected materials
- Inform QA for risk assessment
- Record deviation and corrective action
- Initiate CAPA if recurring deviations are observed.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
- RH: Relative Humidity
7. Documents
- Temperature & Humidity Log (Annexure-1)
- Warehouse Cleaning Checklist (Annexure-2)
- Pest Control Schedule (Annexure-3)
- Pest Monitoring Record (Annexure-4)
- Instrument Calibration Log (Annexure-5)
8. References
- ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
- WHO TRS 961 Annex 9 – Guidelines on Storage and Transport of Time- and Temperature-Sensitive Products
- 21 CFR Part 211.42 – Environmental control systems
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 & Humidity Log
| Date | Time | Area | Temperature (°C) | RH (%) | Recorded By |
|---|---|---|---|---|---|
| 13/04/2025 | 09:00 | RM Store | 24.8 | 57 |
Annexure-2: Warehouse Cleaning Checklist
| Date | Area Cleaned | Performed By | Verified By (QA) | Remarks |
|---|---|---|---|---|
| 13/04/2025 | Sampling Room | — |
Annexure-3: Pest Control Schedule
| Month | Agency | Visit Date | Activity Performed | Remarks |
|---|---|---|---|---|
| April 2025 | PestCare Pvt. Ltd. | 05/04/2025 | Fogging + Trapping | OK |
Annexure-4: Pest Monitoring Record
| Date | Location | Trap Type | No. of Pests | Action Taken |
|---|---|---|---|---|
| 13/04/2025 | Quarantine Zone | Glue Trap | 3 | Trap Replaced |
Annexure-5: Instrument Calibration Log
| Date | Instrument ID | Calibrated By | Next Due | Status |
|---|---|---|---|---|
| 01/04/2025 | DATA-001 | Metrologix Labs | 01/10/2025 | OK |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | New Warehouse Setup | QA Head |
| 13/04/2025 | 2.0 | Updated Pest Monitoring and Deviation Handling | Audit Compliance | QA Head |