for sterile injectable products within the facility.

3. Responsibilities

• Packaging Operator: Observe and document room conditions as per frequency defined.
• Engineering Personnel: Maintain HVAC systems and perform calibrations.
• QA Officer: Review records and escalate non-conformities.

4. Accountability

The Quality Assurance Head is accountable for ensuring room monitoring compliance and initiating CAPA for deviations.

5. Procedure

5.1 Monitoring Parameters

1. Record the following parameters at designated frequencies:
   • Temperature
   • Relative Humidity (RH)
   • Pressure Differential
   • Cleanliness Level (Particulate and Microbial)
2. Ensure sensors/probes used are calibrated and traceable.

5.2 Temperature and Humidity

1. Monitor temperature and RH every 4 hours using a digital display unit or data logger.
2. Acceptable limits:
   • Temperature: 18°C to 25°C
   • Relative Humidity: 35% to 65%
3. Record data in Annexure-1: Room Monitoring Log.

5.3 Pressure Differential

1. Ensure pressure gradients between adjacent areas are maintained as per cleanroom classification.
2. Monitor every shift and document in Annexure-2: Pressure Monitoring Sheet.
3. Typical requirement: Minimum 10-15 Pascal between higher and lower classified zones.

5.4 Cleanliness Monitoring

1. Perform particulate count and microbial monitoring weekly or as defined in the Environmental Monitoring Plan.
2. Use calibrated particle counters and active air samplers.
3. Record results in Annexure-3 and Annexure-4.

5.5 Alarm and Alert Handling

1. In case of parameter deviation beyond alert limits:
   • Stop packaging operations immediately.
   • Inform QA and Engineering teams.
   • Document in deviation register and initiate investigation.

5.6 Review and Retention

1. QA shall review room condition logs weekly.
2. Records must be retained for 5 years or as per regulatory guidelines.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• HVAC: Heating, Ventilation, and Air Conditioning
• RH: Relative Humidity

7. Documents

1. Room Monitoring Log – Annexure-1
2. Pressure Monitoring Sheet – Annexure-2
3. Non-Viable Particle Monitoring Report – Annexure-3
4. Viable Monitoring Log – Annexure-4

8. References

• WHO TRS 961 Annex 6: GMP for Sterile Pharmaceutical Products
• ISO 14644 Cleanroom Classification
• EU GMP Vol 4 Annex 1

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: Room Monitoring Log

Date	Time	Temperature (°C)	RH (%)	Checked By
17/06/2025	08:00	22.5	48	Ravi Mehta

Annexure-2: Pressure Monitoring Sheet

Date	Area 1	Area 2	Delta P (Pa)	Checked By
17/06/2025	Primary Pack	Corridor	14	Sachin Nair

Annexure-3: Non-Viable Particle Monitoring Report

Date	Location	≥0.5 µm (cfu/m³)	≥5.0 µm (cfu/m³)	Checked By
14/06/2025	Labeling Room	1,050	80	Preeti Shah

Annexure-4: Viable Monitoring Log

Date	Area	Result (cfu)	Limit	Checked By
14/06/2025	Secondary Packing	2	≤5	Amar Joshi

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2022	1.0	Initial Release	New SOP	Head QA
18/06/2025	2.0	Integrated updated particulate monitoring frequencies	Periodic Review	Head QA