Standard Operating Procedure for Environmental Monitoring in Manufacturing Areas
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/187/2025 |
| Supersedes | SOP/TAB/187/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedures for environmental monitoring in tablet manufacturing areas, ensuring that the cleanliness and environmental conditions are maintained in compliance with regulatory standards.
2. Scope
This SOP applies to all tablet manufacturing areas, including production, packaging, and storage areas. It covers the monitoring of air quality, temperature, humidity, and particulate levels.
3. Responsibilities
- Quality Assurance (QA): Responsible for overseeing the environmental monitoring process, ensuring compliance with regulatory standards, and documenting the results.
- Maintenance Team: Responsible for maintaining equipment used in environmental monitoring and ensuring that the equipment is calibrated and functioning correctly.
- Production Team: Responsible for adhering to environmental control standards and notifying QA of any deviations from established conditions.
- Regulatory Affairs: Responsible for ensuring compliance with applicable environmental regulations and guidelines.
4. Accountability
The QA Manager is accountable for ensuring the environmental monitoring process is executed correctly and that all deviations are investigated and corrected. The department head is responsible for implementing corrective actions when required.
5. Procedure
5.1 Environmental Monitoring Plan
- Develop an environmental monitoring plan that outlines the key parameters to be monitored, including:
- Temperature
- Humidity
- Airborne particulates
- Microbial contamination
- Ensure that monitoring devices and equipment are calibrated before use and at regular intervals as per manufacturer recommendations and regulatory requirements.
- Schedule monitoring activities at appropriate intervals (e.g., daily, weekly, monthly) depending on the manufacturing activity and environmental control requirements.
5.2 Airborne Particulate Monitoring
- Monitor and control the level of airborne particulates in the manufacturing areas using particle counters. Ensure that the monitoring is conducted in both clean and non-clean areas.
- Take samples in strategic locations based on the risk assessment, production schedule, and regulatory requirements.
- Ensure that the number of particles in the air does not exceed the allowable limit defined by the cleanroom classification for the respective manufacturing area.
- Record the results of airborne particulate monitoring and compare them to established limits. Any deviations should be reported and investigated (Annexure-1).
5.3 Microbial Monitoring
- Conduct regular microbial sampling in the manufacturing areas using settle plates, air samplers, or swabs (Annexure-2).
- Ensure that microbial samples are taken from surfaces, equipment, and the air in critical areas where contamination could pose a risk to tablet quality.
- Record the microbial counts and compare them against acceptable limits. Investigate any contamination levels that exceed the established limits.
5.4 Temperature and Humidity Monitoring
- Monitor the temperature and humidity levels continuously in the production and storage areas. Use validated data loggers or thermohygrometers to record data automatically.
- Ensure that temperature and humidity conditions are maintained within the defined ranges for tablet production and storage (e.g., 20°C-25°C and 40%-60% RH).
- In case of deviations from the specified limits, immediately notify the QA department and investigate the cause of the variation (Annexure-3).
5.5 Corrective Actions for Deviations
- If any monitored parameter (e.g., temperature, humidity, airborne particulate level, microbial count) exceeds acceptable limits, the QA team must:
- Investigate the cause of the deviation.
- Implement corrective actions, such as adjusting equipment settings, improving cleaning procedures, or enhancing personnel hygiene.
- Document all actions taken to correct the deviation and prevent recurrence.
- Record all deviations, corrective actions, and follow-up measures in the Environmental Monitoring Log (Annexure-4).
5.6 Documentation and Record Keeping
- Ensure that all environmental monitoring activities are documented, including the date, time, location, and results of monitoring activities (Annexure-5).
- Maintain records of calibration for all monitoring devices and instruments.
- Keep all records of environmental monitoring and corrective actions for at least five years or as required by regulatory guidelines.
5.7 Reporting
- Prepare a summary report of the environmental monitoring activities and findings at regular intervals (monthly or quarterly) and submit it to senior management and regulatory authorities when required.
- Highlight any trends, deviations, and corrective actions taken in the report.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- RH: Relative Humidity
- FDA: Food and Drug Administration
7. Documents
- Environmental Monitoring Log (Annexure-1)
- Microbial Sampling Log (Annexure-2)
- Temperature and Humidity Monitoring Log (Annexure-3)
- Environmental Monitoring Deviation Log (Annexure-4)
- Environmental Monitoring Report (Annexure-5)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 14644-1 – Cleanrooms and Associated Controlled Environments
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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
| Date | Time | Location | Parameter Monitored | Result | Remarks |
|---|---|---|---|---|---|
| 01/03/2026 | 10:00 AM | Production Area | Temperature | 22°C | Within acceptable limits |
Annexure-2: Microbial Sampling Log
| Date | Time | Location | Microbial Count | Action Taken |
|---|---|---|---|---|
| 01/03/2026 | 10:00 AM | Air | 100 CFU/m³ | No action needed |
Annexure-3: Temperature and Humidity Monitoring Log
| Date | Time | Temperature | Humidity | Location |
|---|---|---|---|---|
| 01/03/2026 | 10:00 AM | 22°C | 50% | Production Area |
Annexure-4: Environmental Monitoring Deviation Log
| Date | Deviation | Corrective Action | Responsible Person | Status |
|---|---|---|---|---|
| 01/03/2026 | High temperature | Adjusted air conditioning | John Doe | Resolved |
Annexure-5: Environmental Monitoring Report
| Report ID | Report Date | Parameters Monitored | Result Summary | Actions Taken |
|---|---|---|---|---|
| REP-001 | 01/03/2026 | Temperature, Humidity, Particulates | All within acceptable limits | No action needed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated monitoring protocols | Clarified procedures for microbial sampling and corrective actions | QA Head |