to minimize airborne particulates in production areas.

Laboratory Supervisor: Responsible for overseeing the particulate monitoring process, reviewing data, and ensuring that corrective actions are documented and implemented as required.

4. Accountability

The Production Manager is accountable for ensuring that the monitoring of airborne particulates is carried out as per this SOP. The QC Manager is responsible for overseeing the testing and corrective actions if particulate levels exceed the acceptable range. The Laboratory Supervisor is accountable for reviewing and ensuring that the necessary actions are taken in case of deviations.

5. Procedure

5.1 Pre-Monitoring Setup

1. Ensure that all air monitoring equipment, including particulate counters and air samplers, are calibrated and functional before use. Calibration should be performed according to the manufacturer’s specifications and at regular intervals.
2. Verify that the production area is prepared and clean, with all ventilation systems and air filters in place to minimize particulate contamination during production.
3. Ensure that the monitoring points for airborne particulates are selected in critical production areas, such as near open containers, filling lines, and areas where product contact occurs.
4. Verify that operators are trained to understand the significance of airborne particulates and the methods for maintaining clean room environments.

5.2 Monitoring Airborne Particulates

1. At the beginning of each production run, initiate real-time monitoring of airborne particulates using calibrated air sampling devices.
2. Measure particulate levels at multiple points in the production area, including at various heights and near critical equipment to assess the environment properly.
3. Record the measured levels at regular intervals (e.g., every 30 minutes or as specified in the BMR) to ensure continuous monitoring during production.
4. Ensure that particulate levels do not exceed the acceptable range as specified in the product specifications or the BMR. The typical limit for airborne particulates should not exceed 3 microns in size (class 1000 cleanroom standard) or other specifications as required by the product.
5. Immediately notify the production team and QC team if the particulate levels exceed the acceptable limits and take corrective action, such as halting production or adjusting ventilation systems.

5.3 Handling Deviations

1. If airborne particulates exceed the acceptable limits, stop the production process immediately to prevent contamination of the cream batch.
2. Investigate potential causes of the deviation, such as malfunctioning ventilation, improper cleaning, or contamination from materials or equipment.
3. Implement corrective actions to address the root cause, including cleaning the area, adjusting ventilation systems, or reworking equipment if necessary.
4. Once the cause of the deviation is addressed, resume production, ensuring that the particulate levels are continuously monitored and remain within specification.
5. Document the deviation, corrective actions taken, and final results in the Deviation Report (Annexure-1), and ensure that the report is reviewed and signed by the QC team and Laboratory Supervisor.

5.4 Post-Monitoring Activities

1. After the production process, ensure that all monitoring data is recorded and reviewed for accuracy. If the particulate levels were within the acceptable range, approve the batch for the next stage (e.g., filling or packaging).
2. Ensure that all equipment is cleaned, sanitized, and properly stored after the monitoring process.
3. Review all monitoring records and ensure compliance with GMP and internal cleanliness standards.

5.5 Documentation and Record-Keeping

1. Document all particulate measurements in the Airborne Particulate Monitoring Log (Annexure-2). Ensure that the log includes the time, location, particulate levels, and operator details for each reading.
2. Document any deviations and corrective actions taken in the Deviation Report (Annexure-1), ensuring that all necessary details are captured and signed by the relevant personnel.
3. Ensure that all records are reviewed by the QC team and signed by the operator performing the monitoring. Store all records for a minimum of two years or as required by regulatory guidelines for traceability and compliance.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment
• μm: Micrometer (unit of particulate size)

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: Airborne Particulate Monitoring Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Airborne Particulate Control in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Particulate levels exceeded acceptable range	Re-adjusted ventilation settings	Michael Lee

Annexure-2: Airborne Particulate Monitoring Log

Batch Number	Time	Particulate Level (μm)	Operator	Remarks
12345	09:00 AM	2.5 μm	John Doe	Within specification
12345	12:00 PM	2.8 μm	Jane Smith	Within specification
12345	03:00 PM	3.2 μm	Michael Lee	Exceeded limit, corrective action taken

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head