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
- Quality Control (QC) Team: Responsible for conducting environmental monitoring during the QC process, recording the data, and ensuring compliance with regulatory requirements.
- Quality Assurance (QA) Team: Ensures that the environmental monitoring procedures are followed, reviews the monitoring data for compliance, and investigates any deviations.
- Production Team: Ensures that the capsule manufacturing environment is maintained according to the specified conditions and that equipment is functioning correctly.
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.
5. Procedure
5.1 Pre-Monitoring Setup
Before conducting environmental monitoring, ensure the following:
-
Review Environmental Specifications
- Review the specifications for temperature, humidity, and particulate levels for the capsule manufacturing environment, based on regulatory and internal standards.
-
Prepare Monitoring Equipment
- Ensure that all environmental monitoring equipment (e.g., thermometers, hygrometers, particle counters, etc.) is calibrated and ready for use.
-
Prepare Monitoring Locations
- 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:
-
Monitor Temperature and Humidity
- Use calibrated thermometers and hygrometers to measure the temperature and humidity levels in the manufacturing environment at specified intervals.
- Ensure that temperature and humidity are within the defined acceptable ranges for capsule production, which are typically 20-25°C and 40-60% RH.
-
Monitor Particulate Levels
- 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.
- Ensure that the particulate count remains within the required limits to maintain product quality and prevent contamination of capsule shells.
-
Monitor Airflow and Ventilation
- Check the airflow and ventilation systems to ensure that air circulation is adequate to maintain a clean environment and prevent contamination.
- Record airflow and ventilation status during the monitoring process.
5.3 Post-Monitoring Activities
After completing the environmental monitoring, ensure the following:
-
Review Monitoring Results
- The QA Manager reviews the monitoring data to ensure that all environmental parameters (temperature, humidity, particulate count) fall within the acceptable ranges.
-
Investigate Deviations
- If any parameters are out of specification (OOS), initiate an investigation to identify the cause of the deviation and implement corrective actions.
- Corrective actions may include adjusting environmental controls, repairing malfunctioning equipment, or increasing monitoring frequency.
-
Report and Record Keeping
- Provide the monitoring results and any deviations or corrective actions taken to the relevant authorities or internal stakeholders.
- Ensure that all monitoring data, including raw data and corrective actions, are documented and stored according to GMP and regulatory guidelines.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- RH: Relative Humidity
- ISO: International Organization for Standardization
7. Documents
- Annexure 1: Environmental Monitoring Log
- Annexure 2: Corrective Action Report
- Annexure 3: Calibration Log for Monitoring Equipment
8. References
- ISO 14644-1 – Cleanrooms and Associated Controlled Environments
- USP <797> – Pharmaceutical Compounding – Sterile Preparations
- Good Manufacturing Practice (GMP) Guidelines
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 |