SOP Guide for Pharma

Capsule: SOP for Environmental Monitoring During Capsule QC – V 2.0

Auditor

Capsule: SOP for Environmental Monitoring During Capsule QC – V 2.0

Standard Operating Procedure for Environmental Monitoring During Capsule QC

Department Capsule Manufacturing
SOP No. SOP/CM/199/2025
Supersedes SOP/CM/199/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP provides the procedure for environmental monitoring during the capsule quality control (QC) process to ensure that the manufacturing environment meets the required cleanliness and contamination control standards.

2. Scope

This SOP applies to the capsule manufacturing facility and outlines the methods used to monitor environmental conditions such as temperature, humidity, and particulate levels during capsule production and QC.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring that environmental monitoring is conducted according to GMP and regulatory standards. The QC Supervisor is responsible for carrying out the monitoring process, while the Production Supervisor ensures the proper maintenance of the manufacturing environment.

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5. Procedure

5.1 Pre-Monitoring Setup

Before conducting environmental monitoring, ensure the following:

  1. Review Environmental Specifications
    1. Review the specifications for temperature, humidity, and particulate levels for the capsule manufacturing environment, based on regulatory and internal standards.
  2. Prepare Monitoring Equipment
    1. Ensure that all environmental monitoring equipment (e.g., thermometers, hygrometers, particle counters, etc.) is calibrated and ready for use.
  3. Prepare Monitoring Locations
    1. Identify the areas to be monitored during the QC process, including the capsule manufacturing rooms, storage areas, and any rooms used for sampling or testing.

5.2 Environmental Monitoring Procedure

Follow these steps to conduct environmental monitoring:

  1. Monitor Temperature and Humidity
    1. Use calibrated thermometers and hygrometers to measure the temperature and humidity levels in the manufacturing environment at specified intervals.
    2. Ensure that temperature and humidity are within the defined acceptable ranges for capsule production, which are typically 20-25°C and 40-60% RH.
  2. Monitor Particulate Levels
    1. Use a particle counter to measure airborne particulate levels in the manufacturing environment. This should be done in accordance with ISO class standards for clean rooms.
    2. Ensure that the particulate count remains within the required limits to maintain product quality and prevent contamination of capsule shells.
  3. Monitor Airflow and Ventilation
    1. Check the airflow and ventilation systems to ensure that air circulation is adequate to maintain a clean environment and prevent contamination.
    2. Record airflow and ventilation status during the monitoring process.
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5.3 Post-Monitoring Activities

After completing the environmental monitoring, ensure the following:

  1. Review Monitoring Results
    1. The QA Manager reviews the monitoring data to ensure that all environmental parameters (temperature, humidity, particulate count) fall within the acceptable ranges.
  2. Investigate Deviations
    1. If any parameters are out of specification (OOS), initiate an investigation to identify the cause of the deviation and implement corrective actions.
    2. Corrective actions may include adjusting environmental controls, repairing malfunctioning equipment, or increasing monitoring frequency.
  3. Report and Record Keeping
    1. Provide the monitoring results and any deviations or corrective actions taken to the relevant authorities or internal stakeholders.
    2. Ensure that all monitoring data, including raw data and corrective actions, are documented and stored according to GMP and regulatory guidelines.

6. Abbreviations

7. Documents

  1. Annexure 1: Environmental Monitoring Log
  2. Annexure 2: Corrective Action Report
  3. Annexure 3: Calibration Log for Monitoring Equipment
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8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Environmental Monitoring Log

Location Temperature (°C) Humidity (%) Particulate Count (Particles/m³) Airflow Status Remarks
Capsule Filling Room 23.5 45 35 Normal No deviations

Annexure 2: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 013 Humidity out of range Adjusted HVAC system settings Maintenance Supervisor 03/02/2025

Annexure 3: Calibration Log for Monitoring Equipment

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Thermometer 501 01/02/2025 John Doe Calibration of temperature sensor 01/02/2026

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for environmental monitoring QA Head
01/02/2025 2.0 Updated monitoring method and log format Improvement of environmental monitoring accuracy QA Head
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