Environmental Monitoring Procedures in the Manufacturing Area

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the regular monitoring of environmental conditions, including temperature, humidity, and cleanliness, in the manufacturing area to ensure product quality.

2) Scope

This SOP applies to all manufacturing areas within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting environmental monitoring.
– Facilities personnel must maintain and calibrate monitoring equipment.
– QA personnel are responsible for reviewing and approving the monitoring results.

4) Procedure

1. Monitoring Equipment
1.1. Use calibrated instruments to monitor temperature, humidity, and particulate levels.
1.2. Ensure that all monitoring equipment is regularly calibrated and maintained.
2. Monitoring Frequency
2.1. Conduct temperature and humidity monitoring continuously using automated systems.
2.2. Perform particulate and microbial monitoring at regular intervals as specified in the monitoring plan.
3. Temperature and Humidity Monitoring
3.1. Place temperature and humidity sensors in strategic locations within the manufacturing area.
3.2. Record the temperature and humidity readings continuously using data loggers.
3.3. Set alarm thresholds for temperature and humidity deviations.
4. Particulate Monitoring
4.1. Use particle counters to monitor airborne particulate levels.
4.2. Conduct particulate monitoring during critical manufacturing activities.
4.3. Record particulate levels and compare them against established limits.
5. Microbial Monitoring
5.1. Use settle plates, contact plates, and air samplers to monitor microbial contamination.
5.2. Place settle plates in critical areas and expose them for the specified duration.
5.3. Collect and incubate samples according to standard microbiological procedures.
6. Cleanliness Monitoring
6.1. Perform regular cleaning and sanitization of the manufacturing area as per the cleaning schedule.
6.2. Conduct cleanliness checks to ensure adherence to cleaning procedures.
7. Documentation
7.1. Record all environmental monitoring results in the environmental monitoring log.
7.2. Include details such as date, time, location, and monitoring results.
7.3. Sign and date the monitoring log.
8. Review and Approval
8.1. Submit the completed monitoring logs to the QA department for review.
8.2. QA will review and approve the results based on the criteria outlined in this SOP.
9. Corrective Actions
9.1. If environmental conditions deviate from specified limits, initiate a corrective action report.
9.2. Document all actions taken to address issues identified during monitoring, including potential adjustments to the environmental controls.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Environmental Monitoring Log
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ISO 14644 – Cleanrooms and Associated Controlled Environments

8) SOP Version

Version 1.0