Gel Manufacturing: SOP for Environmental Monitoring Program in Gel Manufacturing Area – V 2.0

Standard Operating Procedure for Environmental Monitoring Program in Gel Manufacturing Area

Department	Gel Manufacturing
SOP No.	SOP/GM/142/2025
Supersedes	SOP/GM/142/2022
Page No.	Page 1 of 12
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To define the procedure for the environmental monitoring (EM) program in the gel manufacturing area to ensure compliance with cGMP and regulatory standards for controlled environments.

2. Scope

This SOP applies to all areas involved in gel manufacturing where environmental control is essential, including cleanrooms, filling zones, storage areas, gowning zones, and airlocks.

3. Responsibilities

Microbiology Lab: Conducts viable and non-viable environmental monitoring.
QA Department: Reviews trends, reports deviations, and ensures compliance with regulatory norms.
Engineering Department: Maintains HVAC and cleanroom integrity.
Production

Department: Facilitates access and supports corrective actions if excursions occur.

4. Accountability

The Head – Quality Assurance is accountable for ensuring the monitoring program is implemented, reviewed, and updated as per risk-based strategies and current guidelines.

5. Procedure

5.1 EM Program Elements

Design the EM program based on cleanroom classification (Grade A to D).
Define sampling locations based on risk assessment and operational impact.
Develop sampling frequency, acceptance criteria, and action/alert limits.

5.2 Types of Monitoring

Non-Viable Monitoring: Using particle counters for 0.5µm and 5.0µm particles.
Viable Air Monitoring: Using active air samplers with appropriate media.
Surface Monitoring: Settle plates, contact plates, and swabs.
Personnel Monitoring: Glove prints, garment swabs post operation.

5.3 Sampling and Incubation

Perform sampling under dynamic and static conditions.
Label plates with area code, date, and operator initials.
Incubate plates: 30–35°C for 3 days and 20–25°C for 5 days (as per organism type).

5.4 Data Recording and Trending

Document all readings in EM logbooks and software (if automated).
Perform monthly trend analysis and highlight deviations.
Investigate and document any excursions beyond alert/action limits.

5.5 Corrective and Preventive Actions (CAPA)

Initiate deviation or incident report for excursions.
Identify root cause and implement CAPA with QA oversight.
Repeat sampling post-CAPA to confirm effectiveness.

5.6 Review and Updates

Review EM program annually or based on major facility/process changes.
Update sampling plans, locations, or limits as per review findings.

6. Abbreviations

EM: Environmental Monitoring
CFU: Colony Forming Unit
CAPA: Corrective and Preventive Action
QA: Quality Assurance
HVAC: Heating, Ventilation, and Air Conditioning

7. Documents

Environmental Monitoring Protocol – Annexure-1
EM Log Sheets – Annexure-2
EM Trend Report – Annexure-3
CAPA Forms – Annexure-4

8. References

EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
WHO TRS 961 – GMP for HVAC and Environmental Control
ISO 14644-1 and ISO 14698

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: EM Protocol Format

Area/Zone
Classification
Sampling Type	Air/Surface/Personnel
Frequency
Alert/Action Limits

Annexure-2: EM Log Sheet

Date	Location	Sample Type	Reading	Remarks

Annexure-3: EM Trend Report Template

Month	Area	CFU Count	Trend	Deviation Noted

Annexure-4: CAPA Form Template

Deviation Ref No.
Root Cause
Corrective Action
Preventive Action
Closure Date

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
20/05/2022	1.0	Initial release	New SOP	QA Head
09/06/2025	2.0	Updated scope, sampling types, and CAPA format	Periodic revision	QA Head