areas, quarantine zones, and warehouses involved in sterile injectable manufacturing.

3. Responsibilities

• Production Operator: Monitors readings and reports deviations.
• QA Personnel: Verifies environmental log data and evaluates trends.
• Engineering Team: Ensures calibration and maintenance of HVAC and monitoring devices.

4. Accountability

The Head of Manufacturing is accountable for ensuring consistent environmental monitoring and timely resolution of excursions beyond defined limits.

5. Procedure

5.1 Monitoring Devices

1. Use calibrated digital temperature and humidity monitors or validated data loggers.
2. Ensure sensors are installed at representative locations (workstations, equipment areas, corners).
3. Calibration must be performed every 6 months or as per the calibration schedule.

5.2 Monitoring Frequency

1. Record temperature and humidity readings at:
   • Beginning of shift
   • Every 4 hours during operation
   • End of shift
2. For automated systems, data should be stored electronically with periodic printouts for record-keeping.
3. Manual entries shall be made in the Environmental Monitoring Log (Annexure-1).

5.3 Acceptable Ranges

1. Grade A/B: Temperature 18–22°C, Relative Humidity (RH) 40–60%
2. Grade C/D: Temperature 20–25°C, RH 40–65%
3. Warehouse/Storage: 25°C ± 2°C, RH NMT 60%

5.4 Action on Deviations

1. If temperature or humidity exceeds action limits:
   • Immediately inform the engineering department.
   • Initiate deviation report and document in Annexure-2.
   • Stop critical operations if environment affects product quality.
2. Resume operation only after conditions return within acceptable limits and QA authorization is obtained.

5.5 Trend Review and Reporting

1. QA shall compile environmental trends monthly for each area.
2. Unusual spikes or drift patterns must be investigated.
3. Summarized reports shall be included in monthly GMP review meetings.

5.6 Preventive Maintenance

1. Engineering shall service air handling units (AHUs), dehumidifiers, and chillers quarterly.
2. Logs of HVAC equipment maintenance shall be reviewed monthly.

5.7 Data Integrity and Record Retention

1. Ensure that data (manual or electronic) is legible, contemporaneous, attributable, and permanent.
2. Records must be retained for not less than five years from date of batch release.

6. Abbreviations

• SOP: Standard Operating Procedure
• RH: Relative Humidity
• QA: Quality Assurance
• HVAC: Heating, Ventilation and Air Conditioning
• AHU: Air Handling Unit
• GMP: Good Manufacturing Practices

7. Documents

1. Environmental Monitoring Log – Annexure-1
2. Temperature/Humidity Deviation Log – Annexure-2
3. Preventive Maintenance Checklist – Annexure-3

8. References

• WHO TRS 961 Annex 6 – GMP for sterile pharmaceutical products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Environmental Monitoring Log

Date	Area	Time	Temperature (°C)	Humidity (%)	Operator
24/06/2025	Filling Room	08:00 AM	20.5	50	Rajesh Kumar

Annexure-2: Temperature/Humidity Deviation Log

Date	Area	Observed Value	Limit	Action Taken	QA Sign
22/06/2025	Solution Room	26°C	25°C	Notified Engineering; Temperature restored	Sunita Reddy

Annexure-3: Preventive Maintenance Checklist

Date	Equipment	Maintenance Activity	Status	Engineer
15/06/2025	AHU-1	Filter Change, Coil Cleaning	Completed	Vinay Pawar

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Updated HVAC reference and annexures	Annual Review	QA Head