Tablets: SOP for Achieving Consistent Tablet Thickness in Manufacturing – V 2.0

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Tablets: SOP for Achieving Consistent Tablet Thickness in Manufacturing – V 2.0

Standard Operating Procedure for Achieving Consistent Tablet Thickness in Manufacturing

Department Tablet
SOP No. SOP/TAB/054/2025
Supersedes SOP/TAB/054/2022
Page No. Page 1 of 7
Issue Date 10/11/2025
Effective Date 15/11/2025
Review Date 10/11/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the steps necessary to achieve consistent tablet thickness during the tablet manufacturing process. Ensuring uniform tablet thickness is essential for product quality, dosage accuracy, and efficient packaging.

2. Scope

This SOP applies to the tablet compression process in which tablet thickness is critical. It includes the setup, monitoring, and adjustment of tablet compression machines to maintain consistent tablet thickness within specified limits.

3. Responsibilities

  • Manufacturing Personnel: Responsible for setting up the tablet compression machine, adjusting parameters, and monitoring tablet thickness during production runs.
  • Quality Control (QC): Responsible for measuring and verifying tablet thickness throughout the production process, ensuring that tablets meet the required specifications.
  • Quality Assurance (QA): Ensures that the process follows the SOP, reviews and approves any changes to the compression settings, and verifies that all records are correctly documented.
  • Maintenance Personnel: Responsible for ensuring that the tablet compression machine is in optimal working condition, performing regular calibrations, and addressing any equipment malfunctions that could affect tablet thickness.

4. Accountability

The Production Manager is accountable for ensuring that tablet thickness is consistently monitored and maintained according to the specifications. The QA Manager ensures compliance with this SOP and verifies that all relevant documentation is complete and accurate.

5. Procedure

5.1 Pre-Compression Setup

  1. Ensure that the tablet compression machine is clean, calibrated, and in good working condition before starting production.
  2. Verify that the appropriate tooling (e.g., punches and dies) is in place, and ensure that they are in good condition, free from wear or damage.
  3. Load the powder blend or granules into the compression machine hopper and ensure that the material meets the required specifications for tablet formation.
  4. Review the batch record to verify the desired tablet thickness and weight specifications. Set the machine parameters, including the compression force, speed, and tablet thickness settings, according to the batch record.
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5.2 Monitoring Tablet Thickness

  1. Start the tablet compression process and monitor tablet thickness in real-time using a micrometer or automated thickness measurement system.
  2. Take samples at regular intervals (e.g., every 30 minutes) to measure tablet thickness. Document the results in the batch record (Annexure-1).
  3. Compare the measured tablet thickness with the target thickness range specified in the batch record. If tablets fall within the acceptable range, continue production.
  4. If the tablet thickness falls outside the acceptable limits, stop the machine immediately and investigate the cause. Possible causes may include variations in compression force, powder feed rate, or tooling conditions.

5.3 Adjusting Compression Force for Consistent Thickness

  1. If the tablet thickness is not within the desired range, adjust the compression force by increasing or decreasing the force applied to the tablet dies.
  2. Increase compression force if the tablets are too thin or brittle, and decrease force if the tablets are too thick or hard.
  3. Make small adjustments to avoid significant changes in tablet characteristics, and re-test tablet thickness after each adjustment.
  4. Document all adjustments made to the compression force in the batch record (Annexure-1), including the reason for the adjustment and the impact on tablet thickness.

5.4 In-Process Monitoring and Re-adjustments

  1. Continuously monitor tablet thickness throughout the production run. Check tablets for any signs of inconsistency in thickness, such as capping or friability.
  2. If a significant deviation from the target thickness occurs, stop the machine and recheck the compression force, material feed, and tooling conditions.
  3. Perform further adjustments if necessary, ensuring that the tablet thickness remains consistent and within the specified limits for the entire batch.
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5.5 Final Tablet Thickness Verification

  1. Once production is complete, perform a final check of the tablet thickness for the entire batch to ensure consistency across all tablets.
  2. If all tablets meet the desired thickness specifications, approve the batch for the next stage of manufacturing (e.g., coating or packaging).
  3. If any tablets deviate from the desired thickness, investigate the cause and take corrective action. Document any deviations and corrective actions in the deviation report (Annexure-2).

5.6 Post-Production Equipment Cleaning

  1. After the compression process is completed, clean the tablet compression machine according to the equipment cleaning SOP to prevent cross-contamination between batches.
  2. Ensure that all tooling (e.g., punches, dies) is cleaned and inspected for wear before being stored for future use.
  3. Document all cleaning activities in the maintenance log (Annexure-3), including the personnel responsible and the time taken to complete the cleaning process.

5.7 Documentation and Record-Keeping

  1. Document all measurements, adjustments, and observations related to tablet thickness in the batch record (Annexure-1).
  2. Any deviations from the specified tablet thickness must be recorded in the deviation report (Annexure-2) along with corrective actions taken to address the issue.
  3. Ensure that all records are signed, dated, and stored according to the company’s retention policy, making them available for audits or regulatory inspections.

5.8 Calibration of Thickness Measurement Equipment

  1. Ensure that the equipment used to measure tablet thickness (e.g., micrometers, automated thickness measurement systems) is calibrated regularly.
  2. Verify calibration before each production run, and perform re-calibration if discrepancies are found.
  3. Document the calibration results in the calibration log (Annexure-4), including the equipment’s serial number and the date of calibration.

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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)
  3. Maintenance Log (Annexure-3)
  4. Calibration Log (Annexure-4)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • 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: Batch Record

Batch Number Tablet Thickness Compression Force Tablet Hardness Comments
Batch 001 0.5 mm 10 kN 7 kg No deviations
Batch 002 0.52 mm 12 kN 8 kg Minor adjustment to force


Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/09/2025 Batch 003 Tablet thickness outside specification Increased compression force to 12 kN John Doe

Annexure-3: Maintenance Log

Maintenance Date Equipment Component Maintenance Performed Performed By Comments
10/09/2025 Tablet Compression Machine Lubrication, Calibration Jane Smith Machine calibrated, no issues found

Annexure-4: Calibration Log

Calibration Date Equipment Calibration Performed By Calibration Results Comments
10/09/2025 Tablet Compression Machine John Doe Compression force verified within acceptable limits Calibration complete, machine ready for use

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 Compression Force and Thickness Parameters Improved Tablet Consistency QA Head
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