environmental monitoring is required, including cleanrooms, HVAC-controlled zones, and sterile compounding areas.

3. Responsibilities

• Microbiology Executive: Executes EM sampling, records results, and alerts QA of deviations.
• Production Supervisor: Facilitates sample collection and coordinates with QC.
• QA Executive: Reviews results and trends for OOS or OOT events and takes corrective action.

4. Accountability

Department Head – Quality Control and Department Head – Manufacturing

5. Procedure

5.1 Types of Environmental Monitoring

1. Airborne particulate monitoring using laser particle counters.
2. Microbial air monitoring through settle plates and active air samplers.
3. Surface monitoring using contact plates or swab tests.
4. Personnel monitoring via finger dab or gown sampling.

5.2 Monitoring Frequency

1. Daily: Settle plates in Class 100/ISO 5 and Class 1000/ISO 6 zones during production.
2. Weekly: Surface and personnel monitoring in Class 100–10000 zones.
3. Monthly: Comprehensive area trend analysis and HVAC system output validation.

5.3 Sampling Locations

1. Defined using risk-based approach (e.g., filling areas, compounding tanks, laminar flow hoods).
2. EM location map to be maintained and verified periodically.

5.4 Procedure for Sampling

1. Prepare settle plates labeled with date, time, location, and operator initials.
2. Place plates for 4 hours under ISO 5 hoods; 2 hours in ISO 7/8 areas.
3. For swabbing, use sterile swabs moistened with diluent and cover 25 cm² area.
4. Transfer samples to microbiology lab within 1 hour of collection.

5.5 Acceptance Criteria

1. Follow Grade A–D classification limits as per EU GMP Annex 1 and WHO guidelines.
2. Trend evaluation to be performed monthly and included in EM summary reports.

5.6 Deviation and Corrective Action

1. Any OOS or OOT observation shall be reported to QA immediately.
2. Investigations shall be conducted using root cause analysis tools.
3. CAPA shall be implemented before resuming production in affected area.

5.7 Documentation

1. EM Logs – Annexure-1
2. EM Summary Reports – Annexure-2
3. EM Deviation Form – Annexure-3

6. Abbreviations

• EM: Environmental Monitoring
• OOS: Out of Specification
• OOT: Out of Trend
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practices

7. Documents

1. EM Log Sheet – Annexure-1
2. EM Trend Summary Report – Annexure-2
3. EM Deviation & Investigation Form – Annexure-3

8. References

• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• WHO TRS 961: Good Manufacturing Practices for Pharmaceuticals
• ISO 14644: Cleanroom and Associated Controlled Environments

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 Sheet

Date	Area	Location	Method	Result	Limits	Initials

Annexure-2: EM Summary Report Format

Month	Area	Total Samples	OOS Count	OOT Count	Remarks

Annexure-3: EM Deviation & Investigation Form

Reference No.
Date
Location
OOS/OOT Observation
Root Cause
CAPA
Closure Date

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/02/2022	1.0	Initial release	New SOP	QA Head
09/06/2025	2.0	Updated sampling frequency and included risk-based approach	Annual revision	QA Head