be Monitored

1. Temperature: Maintained within specified limits based on product and regulatory requirements.
2. Humidity: Controlled to prevent product degradation and microbial growth.
3. Airborne Particulates: Measured using particle counters to assess cleanroom classification.
4. Pressure Differentials: Monitored to prevent cross-contamination between manufacturing areas.
5. Microbiological Contaminants: Monitored in critical production zones using settle plates and air samplers.

5.2. Monitoring Equipment

1. Temperature and humidity sensors should be placed in key areas and calibrated periodically.
2. Airborne particulate monitoring devices should be used in clean zones as per ISO classifications.
3. Pressure differential gauges should be installed at entry points to controlled environments.
4. Microbiological air samplers and surface swab tests should be conducted in accordance with GMP guidelines.

5.3. Monitoring Frequency

1. Temperature and humidity should be recorded every 4 hours using automated data loggers.
2. Airborne particulate levels should be monitored weekly.
3. Pressure differentials should be checked daily and recorded in the Environmental Monitoring Log (Annexure-1).
4. Microbiological sampling should be performed monthly or as per risk assessment requirements.

5.4. Recording and Reviewing Environmental Data

1. All environmental monitoring data should be logged in real-time and stored in the Environmental Monitoring Report (Annexure-2).
2. The QA team should review monitoring records weekly for any trends or deviations.
3. Deviations should be reported in the Environmental Deviation Log (Annexure-3) and investigated immediately.

5.5. Corrective Actions for Environmental Deviations

1. If temperature or humidity exceeds specified limits, immediate corrective action should be taken, such as adjusting HVAC settings or increasing ventilation.
2. If airborne particulate counts exceed limits, production should be halted, and cleaning procedures should be reviewed.
3. If pressure differentials are not maintained, airlock doors should be checked for proper sealing, and the ventilation system should be inspected.
4. Corrective and preventive actions (CAPA) should be documented in the CAPA Log (Annexure-4).

5.6. Calibration and Maintenance of Monitoring Equipment

1. All environmental monitoring devices must be calibrated as per the calibration schedule.
2. Calibration records should be maintained in the Calibration Log (Annexure-5).
3. Maintenance of HVAC systems and air handling units should be conducted quarterly.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• HVAC: Heating, Ventilation, and Air Conditioning
• CAPA: Corrective and Preventive Action
• ISO: International Organization for Standardization

7. Documents

1. Environmental Monitoring Log (Annexure-1)
2. Environmental Monitoring Report (Annexure-2)
3. Environmental Deviation Log (Annexure-3)
4. CAPA Log (Annexure-4)
5. Calibration Log (Annexure-5)

8. References

• Good Manufacturing Practice (GMP) Guidelines
• ISO 14644 – Cleanroom Standards
• FDA Guidance on Environmental Monitoring

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date	Temperature (°C)	Humidity (%)	Pressure Differential	Remarks
06/02/2025	22°C	45%	+10 Pa	Within limits

Annexure-2: Environmental Monitoring Report

Parameter	Recorded Value	Specification	Status
Temperature	22°C	18-25°C	Compliant

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma
01/01/2025	V 2.0	Updated monitoring procedures	GMP Compliance	Anjali Sharma