SOP Guide for Pharma

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

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

Standard Operating Procedure for Environmental Monitoring in Gel Manufacturing Area

Department Gel Manufacturing
SOP No. SOP/GM/172/2025
Supersedes SOP/GM/172/2022
Page No. Page 1 of 10
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To establish a documented procedure for environmental monitoring in the gel manufacturing area, including air, surface, and personnel monitoring, to ensure microbial and particulate contamination control.

2. Scope

This SOP applies to all manufacturing areas designated for gel production and filling, including cleanrooms and controlled environments.

3. Responsibilities

  • Microbiology Analyst: Responsible for performing environmental monitoring activities.
  • Quality Control (QC): Ensures the trend analysis and out-of-specification (OOS) management.
  • Quality Assurance (QA): Oversees compliance and investigates deviations.
  • Production Department: Facilitates access to areas and ensures readiness for monitoring.
See also  Gel Manufacturing: SOP for Labeling and Quarantine of Bulk Gel Batches - V 2.0

4. Accountability

The Head

of Quality Control is accountable for implementing and maintaining the environmental monitoring program.

5. Procedure

5.1 Monitoring Types and Frequency

  1. Viable Air Monitoring: Perform using settle plates and active air samplers weekly in critical areas and monthly in non-critical areas.
  2. Non-Viable Particle Monitoring: Perform with particle counters in Class 100, 1000, and 10,000 environments daily during operations.
  3. Surface Monitoring: Conduct using contact plates (RODAC) on walls, floors, machines, and equipment weekly.
  4. Personnel Monitoring: Execute finger dab testing post-operations for all production personnel at least weekly.

5.2 Sample Collection and Incubation

  1. Label each media plate with date, time, location, and analyst initials before exposure.
  2. Settle plates: Expose for 4 hours at designated locations in critical processing areas.
  3. Contact plates: Apply to surface areas (~25 cm²) with firm and even pressure.
  4. Incubate plates at 30–35°C for 48–72 hours followed by 20–25°C for 72 hours to capture bacterial and fungal growth respectively.
See also  Gel Manufacturing: SOP for Final Release of Packaged Gels - V 2.0

5.3 Acceptance Criteria

  1. Refer to ISO 14644 and internal microbial limits based on room classification.
  2. Document results and compare against alert and action limits.
  3. Generate deviation reports for all OOS results and initiate CAPA.

5.4 Documentation and Trending

  1. Record results in the Environmental Monitoring Log – Annexure-1.
  2. Summarize data in the Environmental Monitoring Summary Sheet – Annexure-2.
  3. Review monthly trends and submit Environmental Monitoring Report – Annexure-3 to QA.

6. Abbreviations

  • QC: Quality Control
  • QA: Quality Assurance
  • OOS: Out-of-Specification
  • RODAC: Replicate Organism Detection and Counting

7. Documents

  1. Environmental Monitoring Log – Annexure-1
  2. Environmental Monitoring Summary Sheet – Annexure-2
  3. Environmental Monitoring Report – Annexure-3
See also  Gel Manufacturing: SOP for Environmental Sustainability in Gel Manufacturing - V 2.0

8. References

  • ISO 14644-1: Cleanroom Classification
  • WHO TRS 961 Annex 6: GMP for Sterile Pharmaceutical Products
  • Schedule M – Good Manufacturing Practices

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation Microbiologist QA Executive Head – Manufacturing
Department Gel Manufacturing Quality Assurance Manufacturing

11. Annexures

Annexure-1: Environmental Monitoring Log

Date Location Type Result (cfu) Analyst
Settle Plate / RODAC / Air Sampler

Annexure-2: Environmental Monitoring Summary Sheet

Month Area Total Samples OOS Samples Comments

Annexure-3: Environmental Monitoring Report

Month
Reviewed By
Approved By
Summary of Trends

Revision History

Revision Date Revision No. Change Description Reason Approved By
10/04/2022 1.0 Initial version New SOP QA Manager
09/06/2025 2.0 Updated sampling procedures Compliance with ISO 14644 and WHO GMP QA Manager
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