Standard Operating Procedure for Environmental Monitoring in Volunteer Areas during BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/117/2025 |
| Supersedes | SOP/BA-BE/117/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for systematic environmental monitoring in volunteer housing, dosing, and recreation areas during the conduct of BA/BE studies to ensure hygienic, safe, and comfortable conditions for study subjects.
2. Scope
This SOP applies to clinical site personnel, housekeeping, and maintenance staff responsible for environmental conditions in areas designated for volunteer accommodation and movement in BA/BE study units.
3. Responsibilities
- Facility Maintenance Officer: Monitors and records temperature, humidity, air changes, and lighting.
- Housekeeping Supervisor: Ensures cleanliness and sanitation as per the defined schedule.
- Clinical Research Coordinator: Ensures volunteer areas are prepared before admission and reports environmental deviations.
- QA Officer: Audits environmental logs and investigates deviations from acceptable limits.
4. Accountability
The Clinical Facility Manager is accountable for maintaining compliant environmental conditions across volunteer areas as per GCP and regulatory guidelines.
5. Procedure
5.1 Environmental Parameters and Frequency
- Monitor and document:
- Room temperature (acceptable: 22°C to 26°C)
- Relative humidity (acceptable: 40% to 60%)
- Air changes per hour (minimum 6 ACH)
- Lighting (minimum 300 lux)
- Use Annexure-1: Environmental Monitoring Log to record values twice per day (morning and evening).
5.2 Equipment and Calibration
- Use calibrated digital thermohygrometers, lux meters, and airflow anemometers.
- Calibrate each device quarterly and maintain certificates in Annexure-2: Equipment Calibration Register.
5.3 Cleanliness and Sanitation
- Ensure daily sweeping, mopping, and surface sanitization of volunteer areas.
- Document activities in Annexure-3: Cleaning and Disinfection Log.
- Ensure availability of clean bedsheets, toiletries, dustbins, and disinfectants.
5.4 Pest Control
- Conduct pest control monthly using agency-approved non-toxic fumigants.
- Document schedule and service records in Annexure-4: Pest Control Log.
5.5 Deviation Handling
- If any parameter exceeds the defined range:
- Inform Maintenance and QA immediately
- Initiate Annexure-5: Environmental Deviation Report
- Implement CAPA and restore normal conditions within 2 hours
5.6 Staff Training
- Train all facility and housekeeping staff quarterly on environmental hygiene SOP.
- Document training in Annexure-6: Training Record.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- GCP: Good Clinical Practice
- QA: Quality Assurance
- ACH: Air Changes per Hour
- CAPA: Corrective and Preventive Action
7. Documents
- Environmental Monitoring Log – Annexure-1
- Equipment Calibration Register – Annexure-2
- Cleaning and Disinfection Log – Annexure-3
- Pest Control Log – Annexure-4
- Environmental Deviation Report – Annexure-5
- Training Record – Annexure-6
8. References
- ICH E6(R2) – Good Clinical Practice
- WHO Guidelines for Volunteer Accommodation
- Schedule Y – Drugs and Cosmetics Rules
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Environmental Monitoring Log
| Date | Time | Room Temp (°C) | RH (%) | ACH | Lighting (Lux) | Checked By |
|---|---|---|---|---|---|---|
| 17/04/2025 | 08:00 AM | 24.2 | 52 | 6.5 | 310 | Rajesh Kumar |
Annexure-2: Equipment Calibration Register
| Device | Model No. | Calibration Date | Next Due | Calibrated By |
|---|---|---|---|---|
| Thermohygrometer | THG-600 | 01/04/2025 | 01/07/2025 | Sunita Reddy |
Annexure-3: Cleaning and Disinfection Log
| Date | Area | Cleaning Time | Supervisor | Remarks |
|---|---|---|---|---|
| 17/04/2025 | Volunteer Dorm A | 07:00 AM | Ajay Verma | Complete |
Annexure-4: Pest Control Log
| Date | Service Agency | Area Covered | Method | Remarks |
|---|---|---|---|---|
| 01/04/2025 | PestSecure India | Dorms, Dining | Fumigation | OK |
Annexure-5: Environmental Deviation Report
| Date | Parameter | Observed Value | Acceptable Range | CAPA |
|---|---|---|---|---|
| 16/04/2025 | Humidity | 67% | 40–60% | AC serviced, dehumidifier used |
Annexure-6: Training Record
| Name | Role | Training Date | Trainer | Remarks |
|---|---|---|---|---|
| Meena Joshi | Housekeeper | 10/04/2025 | QA Officer | Trained |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 05/01/2022 | 1.0 | Initial Release | Regulatory Requirement | QA Head |
| 17/04/2025 | 2.0 | Added monitoring frequency, ACH, lighting metrics, and deviation logs | Internal Audit | QA Head |