SOP Guide for Pharma

Tablets: SOP for pH Monitoring in Coating Suspensions – V 2.0

Auditor

Tablets: SOP for pH Monitoring in Coating Suspensions – V 2.0

Standard Operating Procedure for pH Monitoring in Coating Suspensions

Department Tablet
SOP No. SOP/TAB/144/2025
Supersedes SOP/TAB/144/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for monitoring the pH of coating suspensions used in tablet film coating processes to ensure that the pH remains within the acceptable range for optimal coating quality and stability.

2. Scope

This SOP applies to the monitoring of pH levels in coating suspensions during the film coating process in tablet manufacturing. Ensuring proper pH control is critical for achieving consistent and high-quality coating.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that the pH monitoring process is implemented and that the pH levels are properly controlled during the coating process. The QA Manager is responsible for reviewing and verifying pH control records to ensure compliance.

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5. Procedure

5.1 pH Setup and Calibration

  1. Before starting the coating process, ensure that the pH meter or pH probe is properly calibrated according to the manufacturer’s instructions and the standard operating procedures for calibration.
  2. Verify that the pH probe is clean and free of any residue from previous use.
  3. Set the acceptable pH range for the coating suspension according to the formulation specifications. Typically, this range is between 5.0 and 7.5, but it may vary based on the specific coating material and active ingredients.

5.2 pH Monitoring During Coating Process

  1. During the film coating process, continuously monitor the pH of the coating suspension at regular intervals (e.g., every 30 minutes or after every 100 kg of coated tablets).
  2. Use a properly calibrated pH meter or probe to measure the pH of the suspension. Insert the probe into the suspension and record the pH reading.
  3. If the pH is outside the acceptable range, immediately adjust the pH of the suspension by adding a pH modifier, such as a buffer or acid, based on the desired pH value.

5.3 Corrective Actions

  1. If the pH of the suspension deviates from the specified range, stop the coating process and investigate the cause of the deviation.
  2. Possible causes of pH variation could include incorrect formulation, contamination, or improper storage of the coating solution.
  3. Make the necessary adjustments to the coating suspension, such as adding the appropriate acid or base to bring the pH within the required range.
  4. After adjusting the pH, recheck the pH of the suspension to confirm that it is within the acceptable range before resuming the coating process.
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5.4 Documentation

  1. Record the pH measurements, adjustments made, and any deviations from the specified pH range in the batch record (Annexure-2).
  2. Document any corrective actions taken, including the type and quantity of pH modifiers added, and the time of the pH adjustment in the deviation report (Annexure-1).
  3. Ensure that all records are signed, dated, and reviewed by QA to verify compliance with quality standards.

5.5 Acceptance Criteria

  1. The pH of the coating suspension must remain within the specified range for the entire coating process. If the pH falls outside this range and cannot be corrected, the batch must be evaluated for reprocessing or rejection.
  2. Typical pH specifications for coating suspensions range between 5.0 and 7.5, but this may vary based on the formulation.

5.6 Post-Coating Actions

  1. Once the coating process is completed and the pH has been controlled within the acceptable range, proceed with the next stages of tablet processing, such as drying, packaging, and labeling.
  2. Ensure that the pH meter and any other equipment used in the measurement process are cleaned and calibrated for future use according to the preventive maintenance schedule.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-1)

8. References

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

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 pH exceeded specified range Adjusted pH with acid, rechecked John Doe

Annexure-2: Batch Record

Sample Number pH Value Action Taken
Sample 1 6.2 Accepted

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 real-time monitoring process Improved process monitoring QA Head
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