ancillary operations are carried out.

3. Responsibilities

• Microbiology Analyst: Conducts EM as per the defined schedule and documents results.
• QA Executive: Reviews trends and investigates out-of-limit (OOL) conditions.
• Maintenance Team: Ensures HVAC and HEPA systems are operating within specification.
• Production Officer: Coordinates EM activity with batch production planning.

4. Accountability

Head – Quality Assurance

5. Procedure

5.1 Types of Environmental Monitoring

1. Viable Monitoring: Settle plates, contact plates, swabs, and air sampling.
2. Non-Viable Monitoring: Particulate monitoring using laser particle counters.

5.2 Locations and Frequency

Identify monitoring locations as per the Environmental Monitoring Plan (EMP), covering:

• Class A/B areas: During operations (e.g., filling, open product exposure).
• Class C/D areas: Before and after cleaning, or during peak activity periods.

5.3 Methods and Equipment

1. Settle Plates: Use sterile agar plates exposed for 4 hours at defined locations.
2. Contact Plates: Press on surfaces like benches, gloves, and walls.
3. Swabs: Collect from irregular surfaces using sterile swab sticks.
4. Air Sampling: Use active air samplers (1 m³) near critical points.
5. Particle Counters: Calibrated devices used for airborne non-viable particles.

5.4 Sample Handling

1. Label all plates with location code, date, and analyst initials.
2. Transport samples to microbiology lab in clean containers.
3. Incubate viable samples at 30–35°C for 3 days and 20–25°C for 2 days.

5.5 Limits and Alert Levels

Follow regulatory specifications (EU GMP, WHO TRS 961) for microbial and particulate counts:

• Grade A: <1 CFU / <3520 particles ≥0.5 µm
• Grade B, C, D: Defined as per facility-specific limits in EMP.

5.6 Deviation and OOL Handling

1. Initiate deviation form for OOL events or any EM anomalies.
2. Investigate source (e.g., HVAC failure, gowning breach).
3. Implement CAPA and record all actions taken.

5.7 Trend Analysis

1. Compile monthly trend charts for each monitored location.
2. Use trend data to identify recurrent contamination risks or areas for improvement.

5.8 Record Keeping

1. Maintain all raw data, EM forms, and summary reports.
2. Retain records for a minimum of 5 years or as per regulatory requirement.

6. Abbreviations

• EM: Environmental Monitoring
• OOL: Out of Limit
• HVAC: Heating, Ventilation, and Air Conditioning
• CFU: Colony Forming Units

7. Documents

1. Environmental Monitoring Plan – Annexure-1
2. EM Sampling Log – Annexure-2
3. EM Trend Report Template – Annexure-3

8. References

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

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 Plan

Location	Class	Method	Frequency
Filling Room	A/B	Settle Plates, Air Sampling	Daily
Compounding Room	C	Swab, Contact Plates	Weekly
Corridor	D	Settle Plates	Monthly

Annexure-2: EM Sampling Log

Date	Location Code	Method	Result	Analyst Initials	Comments

Annexure-3: EM Trend Report

Month	Location	CFU Range	Alert Level	Action Taken

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
20/05/2022	1.0	Initial version	New SOP	QA Head
09/06/2025	2.0	Updated to include particle monitoring and revised annexures	Periodic review	QA Head