appropriate actions on deviations or OOT/OOS results.

4. Accountability

The Head – Quality Control is accountable for ensuring microbial monitoring is conducted as per regulatory standards and internal quality policies.

5. Procedure

5.1 Selection of Sampling Points

1. Define sampling locations based on risk assessment, process flow, and area classification (Grade A, B, C, D).
2. Prepare an Environmental Monitoring (EM) location map with unique codes.

5.2 Frequency of Monitoring

1. Perform routine monitoring as per schedule: daily, weekly, monthly, or campaign-based depending on the classification.
2. Conduct additional sampling during equipment breakdowns, maintenance, or after cleaning validation.

5.3 Monitoring Methods

• Active Air Sampling: Use calibrated air samplers (e.g., sieve-type or slit-to-agar) to collect a known volume of air onto agar plates.
• Passive Sampling (Settle Plates): Place open Petri dishes containing appropriate media for a predefined exposure period (typically 4 hours).

5.4 Media and Incubation

1. Use Tryptic Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA) as standard media.
2. Incubate TSA plates at 30–35°C for 48–72 hours and SDA plates at 20–25°C for 5–7 days.

5.5 Acceptance Criteria

Refer to Annexure-3 for acceptance criteria based on cleanroom classification as per EU GMP Annex 1 and WHO TRS guidelines.

5.6 Documentation

1. Record details in the Environmental Monitoring Logbook: area code, date, time, media lot number, sampler ID, and analyst signature.
2. Retain raw data, plate photographs (if applicable), and colony counts in QC records.

5.7 Out of Limit (OOL) or OOS Results

1. Initiate deviation report and perform root cause analysis.
2. Re-sample area after cleaning and disinfection.
3. Quarantine affected batches until investigation is complete.

6. Abbreviations

• EM: Environmental Monitoring
• OOT: Out of Trend
• OOS: Out of Specification
• TSA: Tryptic Soy Agar
• SDA: Sabouraud Dextrose Agar

7. Documents

1. Environmental Monitoring Schedule
2. Monitoring Logbook – Annexure-1
3. Active Air Sampling Report – Annexure-2
4. Acceptance Criteria Table – Annexure-3

8. References

• EU GMP Guidelines – Annex 1
• WHO TRS 961 Annex 6
• FDA Guidance for Industry on Aseptic Processing

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: Monitoring Logbook Format

Date	Area Code	Media Type	Sampler ID	Incubation	CFU Count	Analyst

Annexure-2: Active Air Sampling Report

Sampling Date	Location	Volume (L)	Plate No.	Result (CFU/m3)	Remarks

Annexure-3: Acceptance Criteria Based on Area Classification

Cleanroom Grade	Settle Plate (CFU/4 hrs)	Active Air (CFU/m3)
Grade A	1	1
Grade B	5	10
Grade C	25	100
Grade D	50	200

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
22/04/2022	1.0	Initial version	New SOP implementation	QA Head
09/06/2025	2.0	Added Annexures for acceptance criteria	Annual SOP review	QA Head