Standard Operating Procedure for Environmental Monitoring and Control
1) Purpose
This SOP defines the procedures for environmental monitoring in GMP production areas to ensure control of temperature, humidity, air quality, and contamination levels.
2) Scope
This SOP applies to all personnel involved in environmental monitoring in cleanrooms and controlled areas at [Company Name].
3) Responsibilities
- Operators: Monitor environmental conditions in cleanrooms and controlled areas, record readings, and report deviations.
- Maintenance Team: Ensure that HVAC systems and environmental monitoring equipment are functioning properly and within specifications.
- Quality Assurance (QA): Review environmental monitoring logs and investigate deviations.
4) Procedure
4.1 Environmental Monitoring Setup
4.1.1 Equipment Calibration
- Ensure that temperature, humidity, and particle counters are calibrated before use. Calibration should be performed at regular intervals according to the manufacturer’s instructions.
- Document all calibration activities in the calibration log.
4.1.2 Setting Monitoring Parameters
- Set acceptable ranges for temperature, humidity, and air quality based on GMP guidelines and product specifications. These ranges should be documented in the environmental control log.
4.2 Daily Monitoring Activities
4.2.1 Temperature and Humidity Readings
- Record temperature and humidity levels in controlled areas at regular intervals (e.g., every four
hours). Ensure that readings fall within the acceptable range for the product being manufactured.
In the event of any deviation, notify supervisors and document the deviation in the environmental monitoring log.
4.2.2 Air Quality and Particle Counts
- Measure air quality using particle counters in cleanrooms at least once per shift. Ensure that the particle count does not exceed the allowable limit for the cleanroom classification (e.g., ISO Class 5).
- Document the results of the air quality monitoring in the environmental control log and submit for QA review.
4.3 Post-Operation Activities
4.3.1 Documentation
- Record all environmental monitoring data in the environmental control log, including temperature, humidity, particle counts, and any deviations. Submit logs to QA at the end of each shift.
4.3.2 Maintenance of Monitoring Equipment
- Ensure that all environmental monitoring equipment is cleaned and serviced regularly. Document any maintenance activities in the equipment maintenance log.
- Calibrate monitoring devices on a regular schedule to ensure accuracy. Record all calibrations in the calibration log.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
- HVAC: Heating, Ventilation, and Air Conditioning
6) Documents, if any
- Environmental Control Log
- Calibration Log
- Equipment Maintenance Log
7) References, if any
- ISO 14644: Cleanroom Standards
- Internal SOP for HVAC maintenance
8) SOP Version
Version 1.0
Annexure
1. Environmental Control Log Template
| Date | Room ID | Temperature (°C) | Humidity (%) | Particle Count (ISO Class) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Room Identifier | Temperature Measured | Humidity Measured | Particle Count | Operator Name | QA Name |