the QC laboratory, including analytical testing areas, sample preparation rooms, instrument rooms, and stability chambers.

3. Responsibilities

• QC Analyst: Perform daily environmental checks and document readings in designated logs.
• Maintenance Officer: Calibrate monitoring instruments and perform routine maintenance.
• QA Officer: Review records weekly and ensure deviations are handled per SOP.

4. Accountability

The Head of Quality Control is accountable for ensuring that environmental monitoring activities are conducted as per approved procedures and meet regulatory expectations.

5. Procedure

5.1 Monitoring Schedule

1. Monitoring must be performed:
   • Daily: Temperature, humidity, cleanliness, pressure differentials
   • Weekly: Surface swabs and settle plates (if applicable)
   • Quarterly: Microbiological monitoring in critical areas
2. Monitoring shall be performed in the first hour of laboratory operations each day.

5.2 Temperature Monitoring

1. Use calibrated digital thermometers or temperature data loggers installed in all critical zones.
2. Record temperature from each zone in the Temperature Monitoring Log (Annexure-1).
3. Acceptable limits:
   • General QC Lab: 20°C to 25°C
   • Stability Chamber: As per ICH zone specifications
4. If temperature is out of range, notify maintenance and QA. Log the deviation and initiate impact assessment.

5.3 Humidity Monitoring

1. Use hygrometers or humidity data loggers placed in representative areas.
2. Record %RH values in the Humidity Monitoring Log (Annexure-2).
3. Acceptable limits:
   • QC Lab: 40% to 60% RH
4. For excursions, document the incident, perform root cause analysis, and initiate corrective action.

5.4 Cleanliness Checks

1. Perform daily visual inspection of:
   • Workbenches and instruments
   • Floors and shelves
   • Waste bins and cleaning logs
2. Complete the Cleanliness Checklist (Annexure-3) and take corrective action for non-compliance (e.g., dirty surfaces, spills).

5.5 Pressure Differential Monitoring

1. Verify pressure differentials using manometers or digital gauges at entry points to critical rooms.
2. Acceptable differential: ≥15 Pascal between clean and less clean areas.
3. Document values in Pressure Differential Log (Annexure-4).
4. In case of failure, isolate affected areas and investigate HVAC system performance.

5.6 Equipment Calibration and Maintenance

1. All environmental monitoring instruments must be calibrated quarterly or as per schedule.
2. Calibration certificates must be maintained and tagged to the instrument.
3. Any malfunctioning device must be labeled “Out of Service” and removed from use until recalibrated.

5.7 Deviation and Corrective Action

1. Any parameter outside acceptable range shall be logged as a deviation.
2. Deviation forms shall be initiated and reviewed by QA for potential impact on sample integrity and lab activities.
3. CAPA shall be implemented based on root cause analysis.

5.8 Review and Trending

1. QA shall review all monitoring logs weekly and trend data monthly for compliance and early warning indicators.
2. Environmental trends shall be included in the Product Quality Review (PQR).

6. Abbreviations

• RH: Relative Humidity
• CAPA: Corrective and Preventive Action
• PQR: Product Quality Review
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. Temperature Monitoring Log (Annexure-1)
2. Humidity Monitoring Log (Annexure-2)
3. Cleanliness Checklist (Annexure-3)
4. Pressure Differential Log (Annexure-4)
5. Deviation Forms

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO TRS No. 961 Annex 5 – GMP for Quality Control Laboratories
• 21 CFR Part 211 – Subpart I

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	Area	Temperature (°C)	Observed By	Remarks
14/04/2025	Instrument Room	22.4	Rajesh Kumar	Within limits

Annexure-2: Humidity Monitoring Log

Date	Area	% RH	Observed By	Remarks
14/04/2025	Sample Prep Area	45%	Sunita Reddy	Acceptable

Annexure-3: Cleanliness Checklist

Area	Cleaned (Yes/No)	Inspector	Date	Remarks
HPLC Bench	Yes	Anil Mehta	14/04/2025	NA

Annexure-4: Pressure Differential Log

Date	Area	Reading (Pa)	Recorded By	Remarks
14/04/2025	Between Corridor and QC Lab	17	Priya Nair	Acceptable

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP issued	System Implementation	QA Head
14/04/2025	2.0	Integrated pressure differential and humidity logging	Regulatory Alignment	QA Head