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

1. 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)
2. Use Annexure-1: Environmental Monitoring Log to record values twice per day (morning and evening).

5.2 Equipment and Calibration

1. Use calibrated digital thermohygrometers, lux meters, and airflow anemometers.
2. Calibrate each device quarterly and maintain certificates in Annexure-2: Equipment Calibration Register.

5.3 Cleanliness and Sanitation

1. Ensure daily sweeping, mopping, and surface sanitization of volunteer areas.
2. Document activities in Annexure-3: Cleaning and Disinfection Log.
3. Ensure availability of clean bedsheets, toiletries, dustbins, and disinfectants.

5.4 Pest Control

1. Conduct pest control monthly using agency-approved non-toxic fumigants.
2. Document schedule and service records in Annexure-4: Pest Control Log.

5.5 Deviation Handling

1. 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

1. Train all facility and housekeeping staff quarterly on environmental hygiene SOP.
2. 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

1. Environmental Monitoring Log – Annexure-1
2. Equipment Calibration Register – Annexure-2
3. Cleaning and Disinfection Log – Annexure-3
4. Pest Control Log – Annexure-4
5. Environmental Deviation Report – Annexure-5
6. 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