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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

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Quality Assurance Specialist
Microbiologist
Environmental Monitoring Technician
Cleanroom Manager
Pharmaceutical Process Engineer
1
Is the cleanroom classified according to ISO 14644 standards?
2
What is the microbial contamination level (CFU/m³) recorded during monitoring?
Min: 0
Target: 0
Max: 10
3
Are environmental control procedures documented and followed?
4
What data integrity practices are in place for environmental monitoring data?
5
Is particle monitoring conducted at the required frequency as per ISO 14644 standards?
6
What is the temperature control accuracy (°C) maintained in the cleanroom?
Min: 18
Target: 20
Max: 22
7
Are personnel trained in cleanroom protocols and environmental monitoring procedures?
8
Describe any corrective actions taken in response to monitoring deviations.
9
Is the monitoring equipment calibrated according to the manufacturer's recommendations?
10
What is the airflow velocity (m/s) in critical areas of the cleanroom?
Min: 0.3
Target: 0.45
Max: 0.7
11
When was the last environmental audit conducted?
12
Provide a summary of the last review of environmental monitoring procedures.
13
Is the cleanroom air quality compliant with ISO 14644 standards?
14
What is the relative humidity level (%) maintained in the cleanroom?
Min: 30
Target: 45
Max: 60
15
How accurate are the records in the environmental monitoring log?
16
Have personnel received training on emergency procedures for cleanroom breaches?
17
Is the environmental monitoring equipment maintained according to the scheduled maintenance plan?
18
What is the airborne particle count (particles/m³) recorded during the last monitoring?
Min: 0
Target: 100
Max: 350
19
What procedures are in place for reporting environmental monitoring incidents?
20
Summarize the findings from the last review of training records for personnel involved in environmental monitoring.

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 of ISO 14644 Environmental Monitoring Audit Checklist

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