non-classified areas within the gel manufacturing section, including blending, holding, filling, and packaging zones.

3. Responsibilities

• Engineering Department: Maintains HVAC system and calibration of monitoring instruments.
• QA Executive: Reviews environmental data and initiates corrective actions when necessary.
• Production Officer: Ensures conditions are within limits during batch execution.
• Microbiology Analyst: Conducts microbiological monitoring of air and surfaces.

4. Accountability

Manager – Quality Assurance

5. Procedure

5.1 Temperature and Humidity Monitoring

1. Install calibrated thermohygrometers in all critical gel processing areas.
2. Record temperature and RH readings every 4 hours using Environmental Monitoring Log – Annexure-1.
3. Acceptable Limits: Temperature: 20–25°C, Relative Humidity: 40–60% unless otherwise specified.
4. Raise deviation and initiate corrective actions if values exceed limits.

5.2 Particle Count Monitoring

1. Conduct non-viable particle count weekly using calibrated laser particle counter.
2. Monitor at rest and in operation for Class 100,000 (ISO 8) or lower areas.
3. Record data in Particle Count Log – Annexure-2.
4. Action limit: Not more than 3,520,000 particles ≥0.5μm/m³.

5.3 Microbial Monitoring

1. Perform settle plate exposure and swab sampling twice weekly.
2. Expose settle plates for 4 hours in representative locations.
3. Collect surface swabs post-cleaning from walls, equipment, and air grills.
4. Incubate samples at 30–35°C for 72 hours.
5. Document findings in Microbial Monitoring Log – Annexure-3.

5.4 Calibration and Maintenance

1. Calibrate thermohygrometers and particle counters quarterly.
2. Maintain HVAC system filter replacement and differential pressure as per schedule.

5.5 Trending and Review

1. QA shall trend environmental data monthly to detect gradual deviations.
2. Initiate CAPA in case of repeat excursions.
3. Include environmental condition summary in Annual Product Quality Review (APQR).

6. Abbreviations

• RH: Relative Humidity
• GMP: Good Manufacturing Practices
• CAPA: Corrective and Preventive Action
• ISO: International Standards Organization

7. Documents

1. Environmental Monitoring Log – Annexure-1
2. Particle Count Log – Annexure-2
3. Microbial Monitoring Log – Annexure-3

8. References

• WHO TRS 961 Annex 6 – GMP for HVAC Systems
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• ISO 14644-1: Classification of Air Cleanliness

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Environmental Monitoring Log

Date	Location	Temperature (°C)	RH (%)	Initials

Annexure-2: Particle Count Log

Date	Location	Particles ≥0.5μm/m³	Particles ≥5μm/m³	Status

Annexure-3: Microbial Monitoring Log

Date	Location	Method (Settle/Swab)	CFU Count	Status

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
22/06/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Updated with trending and APQR linkage	Annual Review	QA Head