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

1. Develop an environmental monitoring plan that outlines the key parameters to be monitored, including:
   • Temperature
   • Humidity
   • Airborne particulates
   • Microbial contamination
2. Ensure that monitoring devices and equipment are calibrated before use and at regular intervals as per manufacturer recommendations and regulatory requirements.
3. 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

1. 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.
2. Take samples in strategic locations based on the risk assessment, production schedule, and regulatory requirements.
3. 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.
4. 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

1. Conduct regular microbial sampling in the manufacturing areas using settle plates, air samplers, or swabs (Annexure-2).
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.
3. 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

1. Monitor the temperature and humidity levels continuously in the production and storage areas. Use validated data loggers or thermohygrometers to record data automatically.
2. 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).
3. 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

1. 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.
2. Record all deviations, corrective actions, and follow-up measures in the Environmental Monitoring Log (Annexure-4).

5.6 Documentation and Record Keeping

1. Ensure that all environmental monitoring activities are documented, including the date, time, location, and results of monitoring activities (Annexure-5).
2. Maintain records of calibration for all monitoring devices and instruments.
3. Keep all records of environmental monitoring and corrective actions for at least five years or as required by regulatory guidelines.

5.7 Reporting

1. 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.
2. 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

1. Environmental Monitoring Log (Annexure-1)
2. Microbial Sampling Log (Annexure-2)
3. Temperature and Humidity Monitoring Log (Annexure-3)
4. Environmental Monitoring Deviation Log (Annexure-4)
5. 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