The Production Manager is accountable for ensuring that viscosity checks are carried out according to the defined procedure. The QC Manager is responsible for verifying the accuracy of viscosity measurements and reviewing documentation. The Laboratory Supervisor oversees the entire process, ensuring compliance with SOPs.

5. Procedure

5.1 Pre-Production Setup

1. Review the batch manufacturing record (BMR) to confirm the required viscosity range for the cream product being produced.
2. Ensure that the viscometer is clean, calibrated, and in proper working condition. Calibration should be done as per the manufacturer’s instructions, and calibration records must be up to date.
3. Ensure that all necessary materials for viscosity testing (e.g., sample containers, viscometer) are available and ready for use.
4. Set up the production line and ensure all ingredients are measured and prepared according to the BMR.

5.2 Performing Viscosity Checks

1. During the production process, take viscosity measurements at predefined intervals (e.g., at the start of the mixing process, after adding key ingredients, and at the end of the mixing cycle).
2. Collect a representative sample of the cream formulation at the appropriate production stage.
3. Use a calibrated viscometer to measure the viscosity of the cream sample. Ensure that the viscometer is properly set up, and the sample is correctly placed in the measurement device according to the manufacturer’s instructions.
4. Record the viscosity reading and compare it to the viscosity specifications stated in the BMR or product specifications. If the viscosity is within the acceptable range, proceed to the next stage of production.
5. If the viscosity reading is outside the specified range, immediately notify the production team to assess the cause of the deviation and make necessary adjustments (e.g., altering mixing speed, adding ingredients).

5.3 Handling Deviations

1. If the viscosity falls outside the acceptable range, stop the production process and investigate the cause of the deviation.
2. Possible causes for viscosity deviations include incorrect ingredient proportions, improper mixing times, or equipment malfunction.
3. Implement corrective actions, such as adjusting the mixing speed, adding thickening agents, or reworking the batch if necessary.
4. Document any deviations in the Deviation Report (Annexure-1), including the cause, corrective action taken, and impact on the batch quality.

5.4 Post-Production Checks

1. After completing the production, perform a final viscosity check to ensure that the product is within specification before moving to the next stage (e.g., filling or packaging).
2. If the final viscosity reading is acceptable, proceed with the filling and packaging process.
3. If the viscosity is still out of specification, the batch may require rework or rejection. In such cases, initiate the rework or rejection process as per the Batch Rework SOP (SOP/CRM/004/2025).

5.5 Documentation and Record-Keeping

1. Record all viscosity measurements, including the time, viscosity reading, and batch number, in the Viscosity Check Log (Annexure-2).
2. Ensure that any deviations and corrective actions are documented in the Deviation Report (Annexure-1).
3. All records must be reviewed by the Laboratory Supervisor to ensure accuracy and compliance with product specifications.
4. Maintain viscosity check records for a minimum of two years or as required by regulatory guidelines.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment
• cP: Centipoise (unit of viscosity)

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: Viscosity Check 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: Viscosity Testing and Quality Control 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	Viscosity exceeded limit	Added thickening agent	Jane Smith

Annexure-2: Viscosity Check Log

Batch Number	Time	Viscosity (cP)	Operator	Remarks
12345	09:00 AM	85	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