dosing rooms, sample collection areas, and monitoring spaces.

3. Responsibilities

• Facility Manager: Ensures infrastructure-related controls are in place and functional (e.g., noise insulation, air filters).
• Clinical Operations Team: Maintains a controlled and calm environment during study periods.
• Security Supervisor: Prevents unauthorized access or disruptions from external sources.
• Quality Assurance (QA): Periodically audits environmental controls and logs deviations.

4. Accountability

The Head of Clinical Operations is accountable for ensuring that the noise and environmental standards outlined in this SOP are adhered to across all active BA/BE studies.

5. Procedure

5.1 Identification of Noise and Disturbance Sources

1. Conduct an Environmental Risk Assessment (Annexure-1) for all clinical zones before each study.
2. Identify possible sources of noise including:
   • Generator or HVAC systems
   • Mobile phones and intercoms
   • Heavy movement of trolleys or beds
   • Subject verbal communication and audio/video devices
3. Identify light or temperature fluctuations that could disturb subjects.

5.2 Infrastructure Controls

1. Install noise-insulating panels in subject dormitories and dosing rooms.
2. Ensure doors are fitted with rubber seals and close gently without slamming.
3. Air conditioning units and generators must be serviced quarterly to reduce mechanical noise.
4. Maintain a Noise Control Equipment Maintenance Log (Annexure-2).

5.3 Operational Controls

1. Restrict all loud conversations, mobile alerts, or announcements within clinical zones during dosing and monitoring windows.
2. Prohibit entry of unauthorized personnel or vendors during active study hours.
3. Assign a designated Environmental Compliance Officer per study to ensure real-time monitoring.
4. Use soft-tread slippers for volunteers and trolleys with noise-absorbing wheels.

5.4 Environmental Monitoring

1. Install sound level meters to measure decibel (dB) levels in:
   • Volunteer sleeping areas
   • Sample collection and processing rooms
2. Maintain Annexure-3: Noise Monitoring Log with three daily readings (morning, afternoon, evening).
3. Alert if readings exceed 60 dB during rest hours (10 PM – 6 AM).

5.5 Subject Briefing and Behavior Control

1. Brief all volunteers on behavior guidelines:
   • Maintain silence during sampling or rest periods
   • Use earphones if watching videos during free time
   • Comply with designated quiet hours
2. Display posters with environmental discipline instructions in vernacular and English.

5.6 Escalation and Corrective Action

1. In case of major noise events (e.g., equipment malfunction or external construction):
   • Document immediately in Annexure-4: Environmental Incident Log
   • Notify the Clinical Operations Head
   • Activate alternate sleeping or dosing arrangements if prolonged
2. Implement corrective and preventive action (CAPA) as needed.

5.7 Audit and Review

1. QA to conduct quarterly audits using Annexure-5: Noise Compliance Checklist.
2. Records to be archived in the Trial Master File for minimum of 5 years.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• QA: Quality Assurance
• HVAC: Heating, Ventilation, and Air Conditioning
• CAPA: Corrective and Preventive Action

7. Documents

1. Environmental Risk Assessment – Annexure-1
2. Noise Control Equipment Maintenance Log – Annexure-2
3. Noise Monitoring Log – Annexure-3
4. Environmental Incident Log – Annexure-4
5. Noise Compliance Checklist – Annexure-5

8. References

• WHO Guidelines for Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules
• ICH E6(R2) – Good Clinical Practice

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 Risk Assessment

Zone	Identified Risks	Control Measures	Verified By
Volunteer Room	Nearby generator noise	Soundproof window panels	Rajesh Kumar

Annexure-2: Noise Control Equipment Maintenance Log

Equipment	Last Serviced On	Next Due	Remarks
Air Conditioner (Block B)	01/04/2025	01/07/2025	Working

Annexure-3: Noise Monitoring Log

Date	Time	Location	Reading (dB)	Recorder
16/04/2025	10:00 AM	Dosing Room	52	Sunita Reddy

Annexure-4: Environmental Incident Log

Date	Issue	Zone	Corrective Action	Resolved On
15/04/2025	Construction noise from adjacent site	Volunteer Dorm	Subjects shifted to alternate wing	16/04/2025

Annexure-5: Noise Compliance Checklist

Audit Date	Checked Areas	Compliance Status	Auditor Name
15/04/2025	Clinical Zones A & B	Compliant	Vinay Pawar

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
17/04/2025	2.0	Annexures added, expanded controls	Environmental audit feedback	QA Head