Standard Operating Procedure for Noise Pollution Monitoring in Pharmaceutical Facilities

1) Purpose

The purpose of this SOP is to outline a standardized procedure for monitoring, evaluating, and mitigating noise pollution in pharmaceutical facilities to ensure compliance with regulatory standards and safeguard employee health and well-being.

2) Scope

This SOP applies to all areas of the pharmaceutical facility where noise levels may pose risks to employees or violate environmental regulations.

3) Responsibilities

• EHS Manager: Oversee noise monitoring activities and ensure compliance with regulatory limits.
• Monitoring Team: Conduct noise assessments, document results, and recommend mitigation measures.
• Supervisors: Implement noise control measures and ensure employee adherence to hearing protection protocols.
• Employees: Report excessive noise levels and use hearing protection as required.

4) Procedure

4.1 Planning Noise Monitoring

1. Identify Monitoring Areas:
   • Determine high-noise areas such as manufacturing lines, HVAC systems, and utility rooms.

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2. Set Monitoring Frequency:
   • Conduct noise monitoring quarterly or as required by local regulations and operational changes.
3. Define Regulatory Limits:
   • Refer to local noise standards, such as OSHA or ISO guidelines, to establish acceptable noise levels.

4.2 Conducting Noise Monitoring

1. Use Approved Instruments:
   • Utilize calibrated sound level meters or dosimeters for accurate noise measurement.

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2. Measure Noise Levels:
   • Record noise levels at various points in high-noise areas and during peak operational hours.
3. Document Observations:
   • Log noise data, including location, time, and decibel levels, in the Noise Monitoring Log (Annexure 1).
4. Analyze Results:
   • Compare recorded noise levels with permissible exposure limits to identify non-compliance or risk areas.

4.3 Implementing Mitigation Measures

1. Engineering Controls:
   • Install noise barriers, sound-absorbing materials, or mufflers to reduce noise at the source.

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2. Administrative Controls:
   • Restrict access to high-noise areas, schedule noisy operations during off-peak hours, and rotate staff to minimize exposure.
3. Provide Hearing Protection:
   • Distribute earplugs or earmuffs to employees working in high-noise areas and ensure proper usage.

4.4 Training and Awareness

1. Conduct Training:
   • Provide employees with training on the health risks of noise exposure and the importance of hearing protection.

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2. Promote Awareness:
   • Display signage in high-noise areas indicating required hearing protection and permissible noise limits.
3. Encourage Reporting:
   • Establish a reporting mechanism for employees to notify supervisors of excessive noise levels or faulty equipment.

4.5 Documentation and Reporting

1. Maintain Records:
   • Keep noise monitoring logs, training attendance sheets, and equipment maintenance records for audits.

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2. Prepare Reports:
   • Compile quarterly or annual noise monitoring reports summarizing findings, mitigation measures, and compliance status (Annexure 2).
3. Submit to Authorities:
   • Provide reports to regulatory agencies as required during inspections or compliance audits.

4.6 Continuous Improvement

1. Review Effectiveness:
   • Evaluate the effectiveness of noise control measures and revise strategies based on feedback and monitoring data.

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2. Update Practices:
   • Incorporate technological advancements or updated regulations into noise monitoring and control practices.
3. Audit Noise Management:
   • Conduct periodic internal audits to ensure sustained compliance with noise control standards.

5) Abbreviations, if any

• EHS: Environmental, Health, and Safety
• OSHA: Occupational Safety and Health Administration

6) Documents, if any

• Noise Monitoring Log
• Noise Mitigation Plans
• Quarterly Noise Monitoring Reports

7) Reference, if any

• OSHA Noise Exposure Standards
• ISO 1996-1:2016 Acoustics – Description, Measurement, and Assessment of Environmental Noise
• Internal EHS Policies

8) SOP Version

Version: 1.0

Annexure

Template 1: Noise Monitoring Log

Date	Location	Time	Noise Level (dB)	Comments
DD/MM/YYYY	Production Area	10:00 AM	85 dB	Within permissible limits

Template 2: Quarterly Noise Monitoring Report

Quarter	Average Noise Level	Non-Compliance Areas	Mitigation Actions
Q1 2024	78 dB	Boiler Room	Installed noise insulation panels