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ISO 14644 Environmental Monitoring Audit Checklist

A detailed checklist for auditing environmental monitoring practices in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on microbial contamination control, particle monitoring, and environmental parameter management.

ISO 14644 Environmental Monitoring Audit Checklist
by: audit-now
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About This Checklist

The ISO 14644 Environmental Monitoring Audit Checklist is a crucial tool for maintaining the integrity of controlled environments in pharmaceutical manufacturing. This comprehensive checklist ensures adherence to ISO 14644 standards for environmental monitoring, addressing key aspects such as microbial contamination, particle counts, and environmental parameters. By systematically evaluating monitoring practices, this checklist helps pharmaceutical companies detect potential contamination risks, maintain product quality, and ensure regulatory compliance. Regular implementation of this checklist can significantly enhance environmental control strategies, improve data integrity, and optimize cleanroom performance.

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Industry

Pharmaceuticals

Standard

ISO 14644

Workspaces

Pharmaceutical Cleanroom

Occupations

Quality Assurance Specialist
Microbiologist
Environmental Monitoring Technician
Cleanroom Manager
Pharmaceutical Process Engineer

Environmental Monitoring Practices Audit

(0 / 4)

1
What data integrity practices are in place for environmental monitoring data?

Describe the data integrity practices implemented.

Ensuring data integrity is vital for regulatory compliance and quality assurance.
2
Are environmental control procedures documented and followed?

Select the status of environmental control procedures.

Documented procedures ensure consistency and compliance with regulatory standards.
3
What is the microbial contamination level (CFU/m³) recorded during monitoring?

Enter the number of CFU per cubic meter.

Monitoring microbial contamination levels is crucial for ensuring product safety and compliance.
Min: 0
Target: 0
Max: 10
4
Is the cleanroom classified according to ISO 14644 standards?

Select the compliance status of the cleanroom classification.

Compliance with ISO 14644 ensures that the cleanroom meets the required standards for particle levels.
5
Describe any corrective actions taken in response to monitoring deviations.

Provide details on corrective actions implemented.

Documenting corrective actions is necessary for continuous improvement and compliance.
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6
Are personnel trained in cleanroom protocols and environmental monitoring procedures?

Indicate whether personnel training is compliant.

Training ensures that personnel are knowledgeable about cleanroom operations and compliance requirements.
7
What is the temperature control accuracy (°C) maintained in the cleanroom?

Enter the temperature accuracy in degrees Celsius.

Maintaining accurate temperature control is critical for product stability and compliance.
Min: 18
Target: 20
Max: 22
8
Is particle monitoring conducted at the required frequency as per ISO 14644 standards?

Select the frequency of particle monitoring.

Regular particle monitoring is essential to maintain cleanroom standards and ensure product safety.
9
Provide a summary of the last review of environmental monitoring procedures.

Summarize the findings and changes from the last procedures review.

Regular reviews of monitoring procedures are essential for maintaining compliance and improving practices.
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10
When was the last environmental audit conducted?

Enter the date of the last environmental audit.

Tracking the date of the last audit helps ensure compliance with regular monitoring and assessment.
11
What is the airflow velocity (m/s) in critical areas of the cleanroom?

Enter the airflow velocity in meters per second.

Monitoring airflow velocity is crucial for maintaining cleanroom conditions and preventing contamination.
Min: 0.3
Target: 0.45
Max: 0.7
12
Is the monitoring equipment calibrated according to the manufacturer's recommendations?

Select the calibration status of the monitoring equipment.

Proper calibration of monitoring equipment ensures accurate measurements and compliance with standards.
13
Have personnel received training on emergency procedures for cleanroom breaches?

Indicate whether personnel training on emergency procedures is completed.

Training personnel on emergency procedures is essential for risk management and safety.
14
How accurate are the records in the environmental monitoring log?

Describe the accuracy of the monitoring log entries.

Accurate record-keeping is necessary for compliance and traceability of monitoring activities.
15
What is the relative humidity level (%) maintained in the cleanroom?

Enter the relative humidity percentage.

Controlling humidity levels is essential for preventing microbial growth and ensuring product integrity.
Min: 30
Target: 45
Max: 60
16
Is the cleanroom air quality compliant with ISO 14644 standards?

Select the compliance status of the cleanroom air quality.

Ensuring air quality compliance is vital for maintaining a contamination-free environment.
17
Summarize the findings from the last review of training records for personnel involved in environmental monitoring.

Provide details on the training records review findings.

Regular reviews of training records ensure that personnel are adequately trained and compliant.
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18
What procedures are in place for reporting environmental monitoring incidents?

Describe the incident reporting procedures for environmental monitoring.

Clear reporting procedures are essential for addressing issues promptly and ensuring compliance.
19
What is the airborne particle count (particles/m³) recorded during the last monitoring?

Enter the airborne particle count in particles per cubic meter.

Tracking airborne particle counts is essential for cleanroom safety and compliance with standards.
Min: 0
Target: 100
Max: 350
20
Is the environmental monitoring equipment maintained according to the scheduled maintenance plan?

Select the maintenance status of the environmental monitoring equipment.

Regular maintenance of monitoring equipment is crucial to ensure accurate and reliable performance.

FAQs

The checklist covers air and surface microbial monitoring, non-viable particle counting, temperature and humidity monitoring, pressure differential checks, and personnel monitoring practices.

It ensures that environmental monitoring data is collected, recorded, and analyzed according to ISO 14644 standards, promoting accuracy, consistency, and traceability in cleanroom data management.

The audit should involve quality assurance personnel, microbiologists, cleanroom operators, and environmental monitoring specialists to ensure a comprehensive evaluation of all aspects of the monitoring program.

The frequency depends on the criticality of the cleanroom, but typically, comprehensive audits should be conducted at least quarterly, with more frequent checks for critical parameters.

Any non-compliance should trigger a thorough investigation, root cause analysis, and implementation of corrective and preventive actions (CAPA) to address the issues and prevent recurrence.

Benefits

Ensures comprehensive environmental monitoring in compliance with ISO 14644

Helps identify and mitigate potential contamination risks in cleanrooms

Supports data-driven decision making for cleanroom management

Facilitates continuous improvement of environmental control strategies

Aids in maintaining regulatory compliance and audit readiness