– Temperature: Must be maintained within specified limits to prevent degradation of materials.
– Humidity: Controlled to prevent moisture-related issues, such as mold or corrosion.
– Airborne Particulates: Monitor to ensure that particle levels do not exceed acceptable limits.
– Airflow and Pressure: Ensure proper airflow and pressure differentials to prevent contamination.
– Microbial Contamination: Regular sampling of surfaces and air to detect microbial growth.

4.1.2 Acceptable Limits
– Establish acceptable limits for each parameter, based on:
– Manufacturer specifications.
– Industry standards (e.g., ISO 14644 for cleanrooms).
– Regulatory requirements (e.g., FDA, EU MDR).

4.2 Environmental Monitoring Equipment
4.2.1 Selection of Monitoring Tools
– Use calibrated equipment for accurate data collection, such as:
– Digital thermometers and hygrometers for temperature and humidity.
– Particle counters for airborne particulates.
– Pressure sensors and airflow monitors.
– Microbial sampling devices (e.g., air samplers, surface swabs).

4.2.2 Calibration and Maintenance
– Ensure that all monitoring equipment is calibrated regularly, and maintain calibration records.
– Perform routine maintenance and functionality checks of monitoring devices to ensure accurate readings.

4.3 Monitoring Procedures
4.3.1 Continuous Monitoring
– Set up continuous monitoring systems for critical environmental parameters such as temperature, humidity, and airborne particulates.
– Use automated systems that provide real-time data and alerts for out-of-spec conditions.

4.3.2 Periodic Monitoring
– Conduct regular manual checks for parameters that cannot be continuously monitored, such as:
– Microbial contamination (e.g., surface sampling or air quality checks).
– Airflow and pressure levels.
– Record monitoring results in the Environmental Monitoring Log.

4.3.3 Sampling and Testing
– Perform regular sampling of the air and surfaces in the manufacturing areas to detect microbial contamination.
– Collect samples at designated intervals and locations based on the risk of contamination in specific areas.

4.4 Data Recording and Documentation
4.4.1 Environmental Monitoring Log
– Maintain an Environmental Monitoring Log to document:
– Date and time of monitoring.
– Parameters monitored (e.g., temperature, humidity, particulate count).
– Measurement results and any deviations from acceptable limits.
– Corrective actions taken for any deviations.

4.4.2 Trend Analysis
– Perform periodic trend analysis of environmental monitoring data to identify patterns or recurring issues.
– Investigate any trends that may indicate equipment malfunctions, environmental changes, or contamination risks.

4.4.3 Reporting
– Generate periodic environmental reports summarizing monitoring results, corrective actions, and trend analysis findings.
– Share reports with QA and regulatory affairs for review and action.

4.5 Corrective and Preventive Actions (CAPA)
4.5.1 Identifying Deviations
– Identify deviations from acceptable environmental conditions, such as:
– Temperature or humidity exceeding limits.
– Particulate levels exceeding the specified threshold.
– Microbial contamination detected during testing.

4.5.2 Corrective Actions
– Implement corrective actions to address deviations, such as:
– Repairing malfunctioning monitoring equipment.
– Adjusting HVAC systems to maintain temperature and humidity levels.
– Cleaning and disinfecting areas with contamination issues.

4.5.3 Preventive Actions
– Develop preventive actions to avoid recurrence of environmental issues, including:
– Upgrading monitoring systems.
– Revising cleaning and maintenance schedules.
– Enhancing staff training on contamination control practices.

4.5.4 Documentation of CAPA
– Record all corrective and preventive actions taken in the CAPA Log, including:
– Description of the deviation.
– Corrective actions implemented.
– Preventive measures for future prevention.

4.6 Compliance and Regulatory Requirements
4.6.1 Regulatory Compliance
– Ensure that environmental monitoring practices comply with:
– FDA 21 CFR Part 820: Quality System Regulation.
– ISO 14644: Cleanrooms and associated controlled environments.
– EU MDR (Regulation (EU) 2017/745) for general safety and performance requirements.

4.6.2 Regulatory Inspections
– Provide environmental monitoring data and documentation during regulatory inspections or audits.
– Ensure that all monitoring systems and records are up-to-date and readily accessible for inspection.

4.7 Documentation and Record Keeping
4.7.1 Environmental Monitoring File
– Maintain a file containing:
– Environmental monitoring logs.
– Calibration certificates for monitoring equipment.
– CAPA records related to environmental deviations.
– Reports from regulatory inspections.

4.7.2 Retention Period
– Retain records for a minimum of five years or as required by regulatory authorities.

5) Abbreviations

– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions
– SOP: Standard Operating Procedure
– FDA: Food and Drug Administration
– ISO: International Organization for Standardization
– EU MDR: European Medical Device Regulation

6) Documents

– Environmental Monitoring Log
– Environmental Monitoring Reports
– CAPA Log
– Calibration Certificates
– Regulatory Submission Documents

7) Reference

– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 14644: Cleanrooms and Associated Controlled Environments
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
– ISO 13485: Medical Devices – Quality Management Systems

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Environmental Monitoring Log Template

Date	Test ID	Parameter Monitored	Result	Corrective Actions Taken
DD/MM/YYYY	EM-001	Particle Count	Pass	No action required

Annexure 2: CAPA Log Template

Date	CAPA ID	Description of Deviation	Corrective Action	Preventive Action
DD/MM/YYYY	CAPA-001	Humidity level exceeded 60%	HVAC system recalibrated	Monthly calibration checks implemented