SOP Guide for Pharma

Tablets: SOP for Compression Weight Control During Tablet Manufacturing – V 2.0

Auditor

Tablets: SOP for Compression Weight Control During Tablet Manufacturing – V 2.0

Standard Operating Procedure for Compression Weight Control During Tablet Manufacturing

Department Quality Control
SOP No. SOP/TAB/121/2025
Supersedes SOP/TAB/121/2022
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 controlling tablet weight during the compression process, ensuring that the final tablet weight meets the specified target range.

2. Scope

This SOP applies to the tablet compression process, specifically for monitoring and controlling the weight of tablets during compression to ensure uniformity and adherence to product specifications.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that tablet weights are monitored, controlled, and adjusted as required to meet product specifications. The QA Manager is responsible for reviewing records and ensuring compliance with this SOP.

See also  Tablets: SOP for Disintegration Testing for Immediate Release Tablets - V 2.0

5. Procedure

5.1 Sample Collection

  1. During tablet compression, collect a representative sample of tablets from the compression machine at regular intervals, typically every 15 minutes or as specified by the batch record.
  2. Ensure that the sample size is sufficient to obtain an accurate representation of the entire batch (usually a minimum of 10 tablets per sample).

5.2 Tablet Weight Measurement

  1. Weigh each tablet from the collected sample using a calibrated balance, ensuring that the balance is properly zeroed before each measurement.
  2. Record the weight of each tablet on the tablet weight log (Annexure-2), ensuring that the measurement is accurate to the nearest milligram or gram, depending on the tablet size.
  3. Calculate the average weight of the tablets in the sample and compare it to the target weight.

5.3 Weight Control Adjustments

  1. If the average tablet weight deviates from the target by more than the acceptable limit (typically ±5% of the target weight), make adjustments to the compression machine settings.
  2. Adjust the tablet weight by changing the fill weight, tablet press speed, or machine pressure settings as appropriate.
  3. After adjustments, re-sample and measure the weight of the tablets to verify that the adjustments resulted in tablets meeting the desired weight specification.
  4. Continue monitoring tablet weight throughout the compression process, making further adjustments if necessary.
See also  Tablets: SOP for Sampling Plan for In-Process Tablet Testing - V 2.0

5.4 Monitoring and Documentation

  1. Record the following information during each tablet weight monitoring interval:
    • Sample number and time of collection
    • Individual tablet weights
    • Average tablet weight
    • Deviation from target weight and any adjustments made
  2. Document any deviations from the target weight and corrective actions taken in the deviation report (Annexure-1).

5.5 Acceptance Criteria

  1. The tablet weight must be within the acceptable range of ±5% of the target weight.
  2. If the weight deviation exceeds the acceptable limit, the batch may be rejected or reworked, and corrective actions must be taken to prevent recurrence.
  3. If the deviations are within the acceptable limit, the batch can proceed to the next stage of production.

5.6 Post-Compression Actions

  1. After ensuring the tablet weight is within specification, proceed with other post-compression processes, such as coating, packaging, and storage.
  2. Ensure that any adjustments made to the compression machine are recorded and the equipment is cleaned and calibrated as required.

See also  Tablets: SOP for Continuous Tablet Manufacturing Process - V 2.0

6. Abbreviations

7. Documents

  1. Tablet Weight Log (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 Tablet weight deviation > 5% Adjusted tablet fill weight and re-tested John Doe

Annexure-2: Tablet Weight Log

Sample Number Tablet Weight (g) Average Weight (g) Deviation (%) Action Taken
Sample 1 0.500 0.505 ±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 weight variation limits Refined weight control criteria QA Head
Exit mobile version