SOP Guide for Pharma

Tablets: SOP for Process Troubleshooting in Tablet Manufacturing – V 2.0

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Tablets: SOP for Process Troubleshooting in Tablet Manufacturing – V 2.0

Standard Operating Procedure for Process Troubleshooting in Tablet Manufacturing

Department Tablet
SOP No. SOP/TAB/057/2025
Supersedes SOP/TAB/057/2022
Page No. Page 1 of 8
Issue Date 25/11/2025
Effective Date 30/11/2025
Review Date 25/11/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide a systematic approach to troubleshooting issues that may arise during tablet manufacturing. The goal is to identify and resolve problems such as irregular tablet weight, hardness, capping, or lamination, ensuring consistent production quality and minimal downtime.

2. Scope

This SOP applies to all tablet manufacturing processes, including granulation, tablet compression, and post-compression steps. It covers common issues that can occur during tablet production and outlines procedures for diagnosing and addressing these issues.

3. Responsibilities

4. Accountability

The Production Manager is accountable for overseeing the troubleshooting process during tablet manufacturing and ensuring that issues are identified and resolved efficiently. The QA Manager is responsible for verifying that corrective actions are effective and properly documented.

5. Procedure

5.1 Identifying the Problem

  1. Monitor the tablet manufacturing process closely for any irregularities in tablet properties, such as weight variation, hardness, or defects such as capping and lamination.
  2. If a problem is detected, stop the machine immediately and assess the root cause. Use the tablet testing results from QC (e.g., tablet weight, hardness, thickness) to help identify the issue.
  3. Common problems include:
    • Tablet weight variation
    • Excessive tablet hardness or friability
    • Capping or lamination of tablets
    • Tablets sticking to the dies
    • Inconsistent tablet thickness
  4. Record the issue and start investigating by reviewing the batch record and identifying any discrepancies or deviations from the established process parameters.
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5.2 Troubleshooting Tablet Weight Variation

  1. If tablet weight variation is detected, check the tablet press parameters such as:
    • Compression force
    • Tablet feed rate
    • Material uniformity
    • Tooling condition (e.g., wear and tear of punches and dies)
  2. If weight variation is due to insufficient compression, adjust the compression force settings on the tablet press.
  3. If weight is too high, check for overfeeding of the material and adjust the feeder settings accordingly.
  4. If the problem persists, inspect the tablet press tooling for any signs of wear or damage, as uneven tooling can lead to inconsistent weight. Replace tooling as necessary.
  5. Document all findings and corrective actions in the batch record (Annexure-1) and update the process if any changes were made to the machine settings.

5.3 Troubleshooting Tablet Hardness and Friability

  1. If tablets are too hard, check the compression force and decrease it gradually to achieve the desired tablet hardness. Increasing compression force beyond the limit may lead to over-hardness.
  2. If tablets are too soft, increase the compression force to achieve the required hardness, but ensure not to exceed the specified limits.
  3. Monitor tablet friability by performing a friability test. If the tablets break easily, inspect the compression force, material properties, and tablet tooling condition.
  4. If friability is high, reduce the compression force and check if the formulation needs to be adjusted (e.g., adding more binders or lubricants).
  5. Ensure that all changes to the compression settings are recorded in the batch record (Annexure-1) along with the reasons for adjustment.

5.4 Troubleshooting Capping and Lamination

  1. Capping and lamination are usually caused by excessive air pressure or inadequate compression force. Review the compression settings and reduce the force if necessary.
  2. Examine the material blend for any inconsistencies such as excessive fines, which could cause poor bonding between granules. Adjust the formula or granulation process if needed.
  3. Check for any material-related issues that could lead to capping, such as insufficient binder or excessive lubricant.
  4. If the issue persists, inspect the tooling for wear, as damaged punches or dies can cause uneven tablet formation leading to capping.
  5. Adjust the compression force and feed rate to optimize tablet formation. Document all actions taken in the batch record (Annexure-1) and report the issue if it remains unresolved.
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5.5 Troubleshooting Sticking and Dragging

  1. If tablets are sticking to the dies or punches, check the lubrication levels and ensure that the lubricant is uniformly mixed into the formulation.
  2. Increase the lubricant concentration if needed, or switch to a different lubricant type suitable for the material.
  3. Inspect the dies and punches for any signs of damage or wear. Clean or replace the tooling if necessary.
  4. Ensure that the tablet press is not overloaded and that the material feed is consistent and free from blockages.
  5. Document all findings and corrective actions in the batch record (Annexure-1) and verify that the issue has been resolved by retesting tablet quality.

5.6 Troubleshooting Inconsistent Tablet Thickness

  1. If tablet thickness is inconsistent, first verify that the tablet press settings are correct and that the die tooling is properly aligned.
  2. Check for any wear on the die set, as worn-out dies can lead to variations in tablet thickness.
  3. Adjust the compression force and tablet feed rate as necessary to ensure that all tablets are within the acceptable thickness range.
  4. If the issue persists, inspect the powder blend for any inconsistencies in particle size distribution or moisture content, as these factors can affect tablet thickness.
  5. Document the adjustments made and verify that tablet thickness is consistent across the batch.
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5.7 Documentation and Record-Keeping

  1. All troubleshooting actions, including identified issues, corrective actions taken, and any process changes, must be thoroughly documented in the batch record (Annexure-1).
  2. Any deviations from the standard process must be recorded in the deviation report (Annexure-2), along with the root cause and corrective actions implemented.
  3. Ensure that all records are signed, dated, and stored according to the company’s retention policy, allowing for future audits and regulatory inspections.

6. Abbreviations

7. Documents

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

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: Batch Record

Batch Number Compression Force Tablet Weight Tablet Hardness Comments
Batch 001 10 kN 500 mg 7 kg No deviations
Batch 002 12 kN 500 mg 8 kg Minor adjustment to compression force

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
10/10/2025 Batch 003 Tablet hardness outside specification Increased compression force John Doe

Annexure-3: Maintenance Log

Maintenance Date Equipment Component Maintenance Performed Performed By Comments
15/09/2025 Tablet Compression Machine Lubrication, Calibration Jane Smith Calibration verified and machine lubricated

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 Troubleshooting Parameters Enhanced Troubleshooting Process QA Head
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