unless specified otherwise for specific raw materials.

Document readings in the Temperature Monitoring Log (Annexure-1).

Humidity Monitoring:

• Monitor and record relative humidity (RH) levels twice daily using hygrometers or automated systems.
• Acceptable humidity range: 30% to 60% RH, with stricter controls for moisture-sensitive materials.
• Document readings in the Humidity Monitoring Log (Annexure-2).

Particulate Monitoring:

• Conduct particulate monitoring monthly using calibrated particle counters in designated areas.
• Ensure levels are within acceptable limits as per ISO Class standards.
• Document results in the Particulate Monitoring Log (Annexure-3).

Microbial Monitoring:

• Perform microbial monitoring monthly using settle plates, contact plates, and air samplers.
• Collect samples from high-touch surfaces, air vents, and other critical areas.
• Document results in the Microbial Monitoring Log (Annexure-4).

5.2 Equipment Calibration and Maintenance

1. Calibration of Monitoring Devices:
   • Ensure all monitoring equipment (thermometers, hygrometers, particle counters) is calibrated quarterly by certified personnel.
   • Maintain calibration certificates and document calibration activities in the Equipment Calibration Log (Annexure-5).
2. Routine Equipment Maintenance:
   • Inspect monitoring equipment weekly for damage or malfunction.
   • Replace batteries, clean sensors, and ensure proper functioning of automated systems.
   • Document maintenance activities in the Equipment Maintenance Log (Annexure-6).

5.3 Handling of Deviations

1. Identification of Deviations:
   • Identify deviations when environmental conditions fall outside the acceptable range.
   • Immediately report deviations to the Warehouse Manager and QA for corrective action.
   • Document deviations in the Environmental Monitoring Deviation Log (Annexure-7).
2. Corrective and Preventive Actions (CAPA):
   • Investigate the root cause of deviations and implement corrective actions such as adjusting HVAC settings or relocating sensitive materials.
   • Document corrective and preventive actions in the CAPA Log (Annexure-8).

5.4 Review and Verification of Monitoring Data

1. Daily Review:
   • Warehouse Supervisors review temperature and humidity logs daily for completeness and accuracy.
   • Document reviews in the Daily Monitoring Review Log (Annexure-9).
2. QA Verification:
   • QA conducts monthly reviews of all environmental monitoring data to ensure compliance with GMP standards.
   • Document verification in the QA Verification Log (Annexure-10).

5.5 Periodic Audits and Reporting

1. Internal Audits:
   • QA conducts quarterly audits of environmental monitoring processes to identify gaps and areas for improvement.
   • Document audit findings in the Environmental Monitoring Audit Log (Annexure-11).
2. Reporting:
   • Prepare quarterly environmental monitoring reports summarizing findings, deviations, and corrective actions.
   • Submit reports to senior management for review.
   • Document reports in the Environmental Monitoring Report Log (Annexure-12).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• RH: Relative Humidity
• CAPA: Corrective and Preventive Actions

7. Documents

1. Temperature Monitoring Log (Annexure-1)
2. Humidity Monitoring Log (Annexure-2)
3. Particulate Monitoring Log (Annexure-3)
4. Microbial Monitoring Log (Annexure-4)
5. Equipment Calibration Log (Annexure-5)
6. Equipment Maintenance Log (Annexure-6)
7. Environmental Monitoring Deviation Log (Annexure-7)
8. CAPA Log (Annexure-8)
9. Daily Monitoring Review Log (Annexure-9)
10. QA Verification Log (Annexure-10)
11. Environmental Monitoring Audit Log (Annexure-11)
12. Environmental Monitoring Report Log (Annexure-12)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ISO 14644 – Cleanrooms and Associated Controlled Environments
• WHO GMP Guidelines

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

Date	Time	Temperature (°C)	Recorded By
19/02/2025	08:00 AM	22°C	Ravi Kumar

Annexure-2: Humidity Monitoring Log

Date	Time	Humidity (%)	Recorded By
19/02/2025	08:00 AM	45%	Sunita Sharma

Annexure-3: Particulate Monitoring Log

Date	Area Monitored	Particle Count (per m³)	Recorded By
01/02/2025	Storage Room A	1,000	Anjali Mehta

Annexure-4: Microbial Monitoring Log

Date	Sample Type	CFU Count	Recorded By
01/02/2025	Settle Plate	3 CFU	Ravi Kumar

Annexure-5: Equipment Calibration Log

Date	Equipment	Calibration Status	Performed By
01/01/2025	Thermometer	Calibrated	Sunita Sharma

Annexure-6: Equipment Maintenance Log

Date	Equipment	Maintenance Performed	Performed By
15/02/2025	Hygrometer	Battery Replacement	Ravi Kumar

Annexure-7: Environmental Monitoring Deviation Log

Date	Deviation	Action Taken	Reported By
10/02/2025	High Humidity (65%)	Adjusted Dehumidifier	Anjali Mehta

Annexure-8: CAPA Log

Date	Issue	Corrective Action	Performed By
11/02/2025	Temperature Fluctuation	Calibrated HVAC System	Ravi Kumar

Annexure-9: Daily Monitoring Review Log

Date	Reviewed By	Findings	Corrective Actions
19/02/2025	Sunita Sharma	All Parameters Within Range	N/A

Annexure-10: QA Verification Log

Date	Verified By	Findings	Corrective Actions
01/02/2025	Anjali Mehta	Compliant	N/A

Annexure-11: Environmental Monitoring Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
01/01/2025	Quarterly Environmental Audit	All Procedures Compliant	N/A	QA Head

Annexure-12: Environmental Monitoring Report Log

Date	Report Period	Findings Summary	Prepared By
01/02/2025	Q1 2025	No Deviations Detected	Anjali Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated GMP Compliance Procedures	Regulatory Compliance	QA Head