QC Manager is accountable for ensuring the correct implementation of environmental monitoring in the QC laboratories. The Laboratory Supervisor is responsible for overseeing day-to-day monitoring activities and ensuring compliance with this SOP.

5. Procedure

5.1 Monitoring of Temperature

1. Monitor and record the temperature in the QC laboratory at regular intervals throughout the day, ensuring that it is within the acceptable range (typically between 20-25°C, as per regulatory requirements).
2. Use calibrated digital thermometers or temperature sensors for accurate readings. Record the temperature in the Temperature Monitoring Log (Annexure-1).
3. If the temperature exceeds or falls below the acceptable range, immediately report the deviation to the Laboratory Supervisor and the Maintenance Team for corrective actions.
4. Ensure that corrective actions, such as adjusting the HVAC system or moving sensitive equipment, are taken and documented.

5.2 Monitoring of Humidity

1. Monitor and record the relative humidity in the QC laboratory at regular intervals throughout the day, ensuring that it remains within the acceptable range (typically between 30-60%, as per regulatory guidelines).
2. Use calibrated hygrometers or humidity sensors for accurate readings. Record the humidity in the Humidity Monitoring Log (Annexure-2).
3. If the humidity falls outside the acceptable range, immediately report the deviation to the Laboratory Supervisor and Maintenance Team for corrective actions.
4. Ensure that corrective actions, such as adjusting the humidity control systems or relocating equipment, are taken and documented.

5.3 Monitoring of Air Quality

1. Monitor the air quality in the QC laboratory to ensure that particulate matter and contaminants are within acceptable levels, using air quality monitoring equipment such as particle counters and air filtration systems.
2. Record air quality readings in the Air Quality Monitoring Log (Annexure-3). Ensure that the air quality equipment is calibrated regularly.
3. If air quality levels exceed the specified limits, immediately report the deviation to the Laboratory Supervisor and Maintenance Team for corrective actions.
4. Ensure that any necessary adjustments to air filtration systems or the placement of sensitive equipment are made, and document the actions taken.

5.4 Equipment Calibration and Maintenance

1. Ensure that all environmental monitoring equipment (e.g., thermometers, hygrometers, air quality monitors) is calibrated annually or as per the manufacturer’s recommendation.
2. Document the calibration dates and ensure that calibration certificates are available for inspection. Maintain records in the Equipment Calibration Log (Annexure-4).
3. Ensure that all equipment used for environmental monitoring is properly maintained. Any malfunctioning equipment should be immediately reported to the Maintenance Team for repair or replacement.

5.5 Documentation and Record-Keeping

1. Ensure that all monitoring activities, including temperature, humidity, and air quality readings, are documented in the appropriate logs (Temperature Monitoring Log, Humidity Monitoring Log, Air Quality Monitoring Log).
2. Ensure that all environmental monitoring records are retained for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Laboratory Supervisor and QA Team to ensure compliance with GMP and regulatory requirements.

5.6 Handling of Deviations

1. If any environmental condition falls outside the acceptable range, a deviation report must be created, and the root cause of the issue must be identified.
2. The deviation report must be reviewed by the Laboratory Supervisor and QA Team, and corrective actions should be taken to resolve the issue. The corrective actions should be documented in the Corrective Action Log (Annexure-5).
3. After corrective actions are taken, the laboratory conditions should be re-evaluated to ensure that the environmental conditions are back within specification.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• HVAC: Heating, Ventilation, and Air Conditioning

7. Documents

1. Annexure-1: Temperature Monitoring Log
2. Annexure-2: Humidity Monitoring Log
3. Annexure-3: Air Quality Monitoring Log
4. Annexure-4: Equipment Calibration Log
5. Annexure-5: Corrective Action Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Environmental Monitoring in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Temperature Monitoring Log

Time	Temperature (°C)	Operator	Remarks
09:00 AM	22°C	John Doe	Within specification

Annexure-2: Humidity Monitoring Log

Time	Humidity (%)	Operator	Remarks
09:00 AM	45%	John Doe	Within specification

Annexure-3: Air Quality Monitoring Log

Time	Particle Count	Operator	Remarks
09:00 AM	50 particles/m³	John Doe	Within specification

Annexure-4: Equipment Calibration Log

Equipment	Calibration Date	Next Calibration Due	Operator
Thermometer	21/01/2026	21/01/2027	John Doe

Annexure-5: Corrective Action Log

Action Date	Deviation Description	Corrective Action Taken	Responsible Person
21/01/2026	Temperature deviation	Adjusted HVAC system	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head