Standard Operating Procedure for Ensuring Weight Uniformity in Tablets

Department	Tablet
SOP No.	SOP/TAB/020/2025
Supersedes	SOP/TAB/020/2022
Page No.	Page 1 of 8
Issue Date	19/05/2025
Effective Date	24/05/2025
Review Date	19/05/2026

1. Purpose

This SOP outlines the procedure for ensuring weight uniformity in tablets during production, ensuring that all tablets meet the specified weight variation limits and comply with quality standards.

2. Scope

This SOP applies to the tablet manufacturing process, covering the weight uniformity checks during and after tablet compression to ensure consistency in tablet weight.

3. Responsibilities

• Manufacturing Personnel: Responsible for ensuring the tablet weight is uniform throughout the production process and adjusting tablet compression settings as necessary.
• Quality Control (QC): Conducts random sampling and testing to verify that the tablet weight meets the required specifications and investigates any deviations.
• Quality Assurance (QA): Ensures that weight uniformity checks are conducted as per this SOP and verifies compliance with regulatory requirements.

4. Accountability

The Production Manager is accountable for ensuring that the weight uniformity is maintained throughout the production run. The QA Manager is responsible for ensuring compliance with this SOP and reviewing the weight uniformity records.

5. Procedure

5.1 Pre-Production Preparation

1. Ensure that all equipment, including the tablet press, balance scales, and tablet sieves, are calibrated and functioning properly.
2. Verify that the tablet formulation is properly prepared, and all raw materials are within their specification limits.
3. Ensure that the machine settings, including compression force and punch/die selection, are set according to the tablet specifications.
4. Confirm that the tablet press is clean and free of any contamination from previous batches, following the cleaning SOP.

5.2 Tablet Compression Process

1. Start the tablet compression process and monitor the tablet weight closely. Ensure that the tablet press is operating at the specified compression speed and force.
2. Ensure that the feed frame and tablet punches are correctly aligned, and there is consistent material flow to avoid irregular tablet formation.
3. Adjust the compression force if necessary to maintain consistent tablet weight. Too high or too low of a compression force can result in weight inconsistencies.
4. Maintain proper tablet ejection from the press to prevent jamming or breakage that can affect tablet weight uniformity.

5.3 In-Process Weight Monitoring

1. Take random samples of tablets from different locations in the batch at regular intervals during the production run (e.g., every 15 minutes or after a set number of tablets).
2. Weigh each tablet using a calibrated balance. Record the weight of each tablet and calculate the average weight of the sample.
3. Ensure that the weight variation falls within the specified limits (usually ±5% of the average weight, depending on the tablet formulation and specifications).
4. If weight variation exceeds the acceptable limit, stop the machine and check for issues such as incorrect material feeding, improper compression settings, or tablet punch misalignment.

5.4 Adjustments and Corrections

1. If any weight variations exceed the acceptable limits, adjust the compression force or machine speed and re-test the tablet weight after adjustments.
2. Ensure that adjustments are made gradually to avoid over-correction, which could cause the tablet weight to deviate further.
3. If adjustments do not resolve the weight inconsistency, consult with QC for further testing and troubleshooting.
4. Document all adjustments made during the process in the batch record (Annexure-1) and specify the reasons for the adjustments.

5.5 Final Tablet Inspection

1. Once the batch has passed the weight uniformity checks, perform a final inspection of the entire batch to confirm that tablet weight, appearance, and dimensions are within specifications.
2. Conduct a final weight check on a representative sample of tablets to ensure uniformity and consistency across the batch.
3. If any tablets are outside the weight variation limit, segregate them for rework or discard them according to SOP.

5.6 Documentation and Record-Keeping

1. Document all weight measurements, adjustments, and corrective actions taken during the production process in the batch record (Annexure-2).
2. Ensure that all records are reviewed by QA personnel and signed off to ensure compliance with internal and regulatory standards.
3. Maintain records of weight checks, deviations, and corrective actions for future reference and audit purposes.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance

7. Documents

1. Batch Record (Annexure-1)
2. Tablet Weight Monitoring Log (Annexure-2)

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 Type	Compression Force (N)	Average Weight (mg)	Variation (%)	Remarks
Batch 001	Tablet A	500	500	±2%	Within specifications
Batch 002	Tablet B	520	510	±3%	Adjustment made

Annexure-2: Tablet Weight Monitoring Log

Batch Number	Tablet Type	Tablet Weight (mg)	Variation (%)	Remarks
Batch 001	Tablet A	500	±2%	Within specifications
Batch 002	Tablet B	510	±3%	Adjustment applied

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 Tablet Weight Monitoring Parameters	Optimization of Weight Uniformity Process	QA Head