Tablets: SOP for End-Point Detection in Compression Process – V 2.0

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Tablets: SOP for End-Point Detection in Compression Process – V 2.0

Standard Operating Procedure for End-Point Detection in Compression Process

Department Tablet
SOP No. SOP/TAB/061/2025
Supersedes SOP/TAB/061/2022
Page No. Page 1 of 7
Issue Date 15/12/2025
Effective Date 20/12/2025
Review Date 15/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for detecting the end-point during the tablet compression process. The goal is to ensure that tablets are compressed to the correct hardness, weight, and thickness, and to determine when to stop the compression process to maintain product consistency and quality.

2. Scope

This SOP applies to the tablet compression process during tablet manufacturing. It focuses on the identification of the end-point for compression, which is based on the tablet characteristics and in-process monitoring. The SOP is applicable to all tablet manufacturing batches that require compression.

3. Responsibilities

  • Manufacturing Personnel: Responsible for monitoring the tablet compression process and detecting the end-point based on tablet characteristics such as hardness, weight, and thickness.
  • Quality Control (QC): Responsible for verifying the tablet characteristics at various intervals and confirming the end-point of compression. QC also ensures that the tablets meet the required specifications.
  • Quality Assurance (QA): Ensures that the procedure for end-point detection follows this SOP and that any deviations from standard process parameters are documented and resolved.
  • Maintenance Personnel: Responsible for ensuring the tablet press is calibrated and in good working condition, and that all related equipment used in the compression process is functioning properly.

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4. Accountability

The Production Manager is accountable for overseeing the tablet compression process, ensuring that the end-point is accurately detected, and confirming that the tablets meet the required specifications. The QA Manager is responsible for verifying compliance with the SOP and ensuring that all deviations are addressed and documented.

5. Procedure

5.1 Preparing for Compression

  1. Ensure that the tablet press is clean and calibrated before starting the compression process. Verify that the tablet press settings are aligned with the batch record specifications.
  2. Prepare the granules or powder blend for compression, ensuring that it meets the required specifications for flowability, particle size distribution, and moisture content.
  3. Ensure that the correct tooling (punches and dies) is installed, and confirm that the tablet press is configured for the correct tablet shape and size as per the batch record.
  4. Set the tablet press parameters, including compression force, tablet thickness, and feed rate, as specified in the batch record.

5.2 Detecting the End-Point of Compression

  1. During the compression process, monitor the key tablet characteristics that determine when to stop the compression, including:
    • Tablet weight
    • Tablet hardness
    • Tablet thickness
  2. Monitor tablet hardness using a hardness tester or in-line measurement system at regular intervals during the compression process.
  3. Check tablet weight consistency using a balance or in-line weight measurement system at regular intervals during the compression process.
  4. Monitor tablet thickness and ensure it remains consistent according to the established parameters.
  5. Once tablets meet the predefined hardness, weight, and thickness criteria, stop the compression process to prevent over-compression, which could lead to defects or unacceptable tablet properties.

5.3 In-Process Monitoring

  1. During the compression process, regularly sample tablets for in-process testing. Measure tablet weight, hardness, and thickness at intervals defined in the batch record (e.g., every 30 minutes or after a specified number of tablets).
  2. If any of the tablet characteristics fall outside the acceptable range, stop the compression process and investigate the cause.
  3. Adjust the compression force, feed rate, or tooling if necessary to bring the tablets back into specification.
  4. Once the tablets meet the required specifications, document the end-point detection and the settings used for compression.
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5.4 Final Verification of Tablet Quality

  1. After the compression process has been stopped, conduct a final check of the tablet characteristics to confirm that the tablets meet the established specifications.
  2. Perform tablet hardness, weight, and thickness testing on a representative sample of tablets from the batch.
  3. Verify that the tablets have a uniform appearance and do not exhibit defects such as capping, lamination, or cracking.
  4. If any tablets fail to meet the specifications, reject the batch or perform rework as necessary according to the batch record and deviation report (Annexure-2).

5.5 Documentation and Record-Keeping

  1. Record all relevant data, including compression settings, tablet weight, hardness, thickness measurements, and any adjustments made during the process, in the batch record (Annexure-1).
  2. Document any deviations from the prescribed process in the deviation report (Annexure-2), and describe the corrective actions taken.
  3. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.6 Calibration and Maintenance of Compression Equipment

  1. Ensure that the tablet press is regularly calibrated to maintain accurate tablet weight, hardness, and thickness measurements.
  2. Perform routine maintenance checks on the tablet press according to the preventive maintenance schedule to ensure optimal performance and minimize the risk of equipment malfunction.
  3. Document all calibration and maintenance activities in the equipment maintenance log (Annexure-3).
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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. Equipment Maintenance Log (Annexure-3)

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 Compression Force Tablet Weight Tablet Hardness Tablet Thickness End-Point Detection Notes
Batch 001 10 kN 500 mg 7 kg 4 mm Compression stopped after achieving target hardness and weight

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
18/12/2025 Batch 002 Tablet hardness outside target range Adjusted compression force John Doe

Annexure-3: Equipment Maintenance Log

Maintenance Date Equipment Component Maintenance Performed Performed By Comments
10/12/2025 Tablet Compression Machine Calibration and Tooling Inspection Jane Smith Calibration verified, tooling in good condition

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 End-Point Detection Parameters Optimized Process QA Head
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