properly during production.

Laboratory Supervisor: Responsible for overseeing the particle size monitoring process, reviewing data, and ensuring compliance with this SOP.

4. Accountability

The Production Manager is accountable for ensuring that inline particle size monitoring is performed as outlined in this SOP. The QC Manager is responsible for verifying the particle size readings and ensuring product quality. The Laboratory Supervisor is accountable for reviewing the particle size data and approving the process before moving to the next stage.

5. Procedure

5.1 Pre-Production Setup

1. Ensure that the inline particle size monitoring system is properly calibrated and verified before the start of production. Calibration should be done according to the manufacturer’s guidelines and frequency outlined in the BMR.
2. Ensure that all monitoring equipment, including sensors and probes, are in good working condition and properly installed at the appropriate points in the production line (e.g., after homogenization).
3. Verify that the cream formulation is prepared according to the recipe, and all raw materials are properly mixed before inline particle size monitoring begins.
4. Ensure that the required particle size range for the cream product is defined in the BMR or product specifications.

5.2 Inline Particle Size Monitoring

1. Monitor particle size in real-time during the cream production process by using the inline particle size monitoring system.
2. The system should continuously measure particle size at defined intervals, typically every 10-15 minutes, depending on the batch size and production speed.
3. Ensure that the particle size readings are continuously displayed and recorded. The particle size should fall within the specified range set in the BMR or product specifications.
4. In case of automated monitoring, ensure that the system is set to trigger an alert if the particle size deviates from the acceptable range. The alert should notify the operator to take corrective action.

5.3 Handling Deviations

1. If the inline particle size readings fall outside the acceptable range, immediately notify the production team and take corrective actions as per the deviation procedure.
2. Investigate the cause of the deviation, which could include issues such as improper mixing, equipment malfunction, or incorrect ingredient proportions.
3. Once the issue is identified, take corrective actions, such as adjusting the homogenizer settings, modifying ingredient proportions, or reworking the batch if necessary.
4. Document the deviation and corrective actions in the Deviation Report (Annexure-1), and ensure the report is reviewed by the QC and Laboratory Supervisors.

5.4 Post-Monitoring Activities

1. After completing the particle size monitoring, ensure that the product meets all required specifications before moving to the next production stage (e.g., filling or packaging).
2. If the particle size is within the acceptable range, approve the batch for the next stage in the production process.
3. If the particle size deviates from the acceptable range, reject the batch or initiate rework according to the Batch Rework SOP (SOP/CRM/004/2025).

5.5 Documentation and Record-Keeping

1. Record all particle size measurements in the Inline Particle Size Monitoring Log (Annexure-2). Ensure that the logs include the time, readings, and any corrective actions taken.
2. Document any deviations and corrective actions in the Deviation Report (Annexure-1), ensuring that the report is signed by the operator and reviewed by the Laboratory Supervisor.
3. Ensure that all records are securely stored and maintained for a minimum of two years or as required by regulatory guidelines.
4. Review all records periodically for accuracy and compliance with product specifications.

6. Abbreviations

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

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: Inline Particle Size 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: Particle Size Monitoring in Cream 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	Particle size outside range	Adjusted homogenizer settings	Jane Smith

Annexure-2: Inline Particle Size Monitoring Log

Batch Number	Time	Particle Size (μm)	Operator	Remarks
12345	10:00 AM	5 μm	John Doe	Within specification

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