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
- Quality Control (QC): Responsible for monitoring tablet weight during the compression process, recording weights, and ensuring that any deviations from the target weight are addressed.
- Compression Operator: Responsible for adjusting the compression machine as necessary to ensure that tablets meet the desired weight specifications during production.
- Quality Assurance (QA): Reviews records and ensures that the weight control procedures are being followed and that any deviations are documented and investigated.
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.
5. Procedure
5.1 Sample Collection
- 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.
- 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
- Weigh each tablet from the collected sample using a calibrated balance, ensuring that the balance is properly zeroed before each measurement.
- 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.
- Calculate the average weight of the tablets in the sample and compare it to the target weight.
5.3 Weight Control Adjustments
- 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.
- Adjust the tablet weight by changing the fill weight, tablet press speed, or machine pressure settings as appropriate.
- After adjustments, re-sample and measure the weight of the tablets to verify that the adjustments resulted in tablets meeting the desired weight specification.
- Continue monitoring tablet weight throughout the compression process, making further adjustments if necessary.
5.4 Monitoring and Documentation
- 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
- Document any deviations from the target weight and corrective actions taken in the deviation report (Annexure-1).
5.5 Acceptance Criteria
- The tablet weight must be within the acceptable range of ±5% of the target weight.
- If the weight deviation exceeds the acceptable limit, the batch may be rejected or reworked, and corrective actions must be taken to prevent recurrence.
- If the deviations are within the acceptable limit, the batch can proceed to the next stage of production.
5.6 Post-Compression Actions
- After ensuring the tablet weight is within specification, proceed with other post-compression processes, such as coating, packaging, and storage.
- Ensure that any adjustments made to the compression machine are recorded and the equipment is cleaned and calibrated as required.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Tablet Weight Log (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <905> – Tablet Weight Variation
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Specifications for Tablet Weight Control
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 |