Standard Operating Procedure for Environmental Monitoring

Purpose

The purpose of this SOP is to establish procedures for monitoring and maintaining the environmental conditions within pharmaceutical manufacturing and storage areas to ensure compliance with regulatory standards and product quality.

Scope

This SOP applies to all personnel involved in environmental monitoring, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for day-to-day monitoring of environmental conditions as specified in this SOP.
• Technicians: Responsible for calibrating and maintaining monitoring equipment and responding to alarms or deviations.
• Quality Control Personnel: Responsible for reviewing environmental monitoring data and ensuring compliance with specifications.

Procedure

1. Place environmental monitoring sensors in designated locations within manufacturing and storage areas.
2. Calibrate monitoring equipment regularly to ensure accurate measurements.
3. Monitor and record temperature, humidity, particle counts, and any other relevant parameters as specified in the environmental monitoring plan.
4. Respond promptly to any alarms or deviations from specified environmental conditions.
5. Investigate and document the cause of any deviations, and implement corrective actions as necessary.
6. Review and analyze environmental monitoring data regularly to identify trends or potential issues.
7. Report any out-of-specification (OOS) results to the quality control department for further investigation.
8. Maintain records of environmental monitoring data, including calibration records, in a secure and organized manner.
9. Archive environmental monitoring records in accordance with established retention policies.
10. Ensure that monitoring equipment is kept clean and well-maintained.
11. Train personnel involved in environmental monitoring on the proper procedures and use of monitoring equipment.
12. Periodically review and update the environmental monitoring plan to reflect changes in processes or regulations.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Environmental Monitoring Plan
• Calibration Records
• Deviation and Corrective Action Logs
• Training Records

Reference

ISO 14644 – Cleanrooms and Associated Controlled Environments

SOP Version

Version 1.0