SOP Guide for Pharma

Gel Manufacturing: SOP for Environmental Monitoring in Gel Production Areas – V 2.0

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Gel Manufacturing: SOP for Environmental Monitoring in Gel Production Areas – V 2.0

Standard Operating Procedure for Environmental Monitoring in Gel Production Areas

Department Gel Manufacturing
SOP No. SOP/GM/197/2025
Supersedes SOP/GM/197/2022
Page No. Page 1 of 9
Issue Date 10/06/2025
Effective Date 12/06/2025
Review Date 10/06/2027

1. Purpose

To lay down the procedure for systematic environmental monitoring in gel manufacturing areas to ensure control of microbial and particulate contamination.

2. Scope

This procedure applies to all controlled areas of the gel manufacturing facility including dispensing, mixing, filling, and packing areas.

3. Responsibilities

  • QA Officer: To perform environmental monitoring and record data.
  • Microbiologist: To analyze samples and report results.
  • Production Supervisor: To ensure readiness and compliance of the area prior to monitoring.

4. Accountability

Head – Quality Assurance is accountable for implementation and compliance with this SOP.

See also  Gel Manufacturing: SOP for Cleaning Verification of Gel Manufacturing Equipment - V 2.0

5. Procedure

5.1 Types of Monitoring

  1. Airborne
Particulate Monitoring: Using particle counter to assess viable and non-viable particles.
  • Settle Plates: Petri dishes placed at key locations to collect settling microorganisms.
  • Surface Monitoring: Swabbing of equipment, walls, and floors.
  • Personnel Monitoring: Contact plates on gloves and gowns.

    • 5.2 Frequency

    1. Daily for Grade A areas.
    2. Weekly for Grade B areas.
    3. Monthly for Grade C and D areas.

    5.3 Sampling Procedure

    1. Ensure that equipment like particle counters and air samplers are calibrated and clean.
    2. Label sampling points clearly as per the Environmental Monitoring Map (Annexure-1).
    3. Use sterile swabs, settle plates, and contact plates for microbial sampling.
    4. Follow unidirectional flow and avoid disturbances during sampling.

    5.4 Limits and Actions

    1. Follow defined alert and action limits as per WHO and GMP guidelines.
    2. Any result beyond action limits must trigger a deviation report and investigation.
    3. Repeated out-of-specification results must lead to area qualification or re-cleaning.

    5.5 Data Recording and Trending

    1. Record all data in the Environmental Monitoring Log (Annexure-2).
    2. Review monthly trends to detect patterns or potential risks (Annexure-3).
    3. QA to prepare quarterly reports for internal audit and management review.

    5.6 Storage and Disposal

    1. After incubation, plates must be documented and disposed of in biohazard waste containers.
    2. Plates showing growth must be labeled and sent for microbial identification.

    6. Abbreviations

    • CFU: Colony Forming Units
    • EM: Environmental Monitoring
    • QA: Quality Assurance
    • GMP: Good Manufacturing Practices

    7. Documents

    1. Environmental Monitoring Map – Annexure-1
    2. EM Log Sheet – Annexure-2
    3. Monthly Trend Analysis Sheet – Annexure-3
    4. Deviation Report Template – Annexure-4
    5. Microbial Identification Record – Annexure-5

    8. References

    • WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
    • EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
    • ISPE Baseline Guide – Cleanroom Design

    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 Map

    Layout map indicating designated EM points with reference numbers.

    Annexure-2: Environmental Monitoring Log

    Date Location Sampling Method CFU Count Remarks

    Annexure-3: Monthly Trend Analysis Sheet

    Month Location CFU Average Out-of-Spec Count Action Taken

    Annexure-4: Deviation Report Template

    Report ID Date Description Root Cause Corrective Action

    Annexure-5: Microbial Identification Record

    Sample ID Source Organism Identified Test Date Microbiologist

    Revision History

    Revision Date Revision No. Change Description Reason Approved By
    15/05/2022 1.0 Initial version New SOP QA Manager
    10/06/2025 2.0 Added microbial identification procedures Regulatory update QA Head
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