Standard Operating Procedure for Real-Time Sampling Plans in Tablet Compression
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/162/2025 |
| Supersedes | SOP/TAB/162/2022 |
| 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 real-time sampling during tablet compression, ensuring that the tablets meet quality standards for weight, hardness, and other physical properties.
2. Scope
This SOP applies to the real-time sampling process used during tablet compression to monitor the quality of the tablets throughout the compression phase of tablet manufacturing.
3. Responsibilities
- Quality Control (QC): Responsible for conducting real-time sampling during tablet compression, ensuring that the samples are representative, and documenting results.
- Production Operator: Responsible for assisting with sample collection during the compression process and notifying QC when samples are required.
- Quality Assurance (QA): Ensures that the real-time sampling procedure is followed as per this SOP and that the process meets product specifications.
4. Accountability
The QC Manager is accountable for ensuring that the real-time sampling procedure is performed as required. The QA Manager is responsible for ensuring that the process is compliant with SOP and quality standards.
5. Procedure
5.1 Preparation for Real-Time Sampling
- Ensure that the tablet compression machine is properly set up for production, with all required tooling, punch sizes, and dies installed.
- Confirm that the necessary sampling tools, such as calibrated balances, collection containers, and labeling materials, are available and ready for use.
- Ensure that the batch record is reviewed to determine the sampling frequency and sampling locations for the compression process.
- Verify that the quality standards for tablet weight, hardness, and other physical properties are established and documented in the batch record.
5.2 Sampling Process During Compression
- Collect samples from different points in the compression process, based on the established sampling plan. Typically, samples should be taken at regular intervals or after every set number of tablets compressed.
- Ensure that the samples are taken from the middle of the compression machine to ensure they are representative of the entire batch.
- Label the samples with batch information, time, and date of sampling to ensure traceability and proper documentation.
- Record the sampling points and times in the batch record (Annexure-2) to ensure that all sample data is accurately documented.
5.3 Physical Testing of Samples
- Weigh each tablet in the sample using a calibrated analytical balance to check for weight variation against the specified limits.
- Test the hardness of each tablet in the sample using a tablet hardness tester to ensure the tablets meet the required hardness range.
- Test other physical properties of the tablet as specified in the batch record (e.g., friability, thickness, or disintegration time).
- Document the results of all physical tests in the batch record (Annexure-2) and note any deviations from the specified limits.
5.4 Documentation of Results
- Record the results of the weight, hardness, and other physical property tests for each sample in the batch record (Annexure-2), including any observations or deviations.
- If a tablet sample fails to meet the specified limits for weight, hardness, or other properties, initiate a deviation report (Annexure-1) and investigate the root cause of the issue.
- Ensure that all results are signed by the responsible QC personnel and reviewed by the QA team for compliance.
5.5 Corrective Actions for Sampling Deviations
- If a sample fails to meet the required standards for any property, investigate potential causes such as incorrect compression settings, faulty tooling, or inconsistent formulation.
- Adjust the compression settings, tooling, or formulation to bring the process back within specification, and re-sample to confirm that the adjustments were effective.
- Document all corrective actions in the deviation report and batch record, and ensure that corrective actions are reviewed and approved by the QA team.
5.6 Acceptance Criteria
- The batch is considered acceptable if all sampled tablets meet the specified weight, hardness, and other physical property limits, as outlined in the batch record and quality specifications.
- If more than 2 tablets in the sample fail to meet the specified limits, the batch will be considered out of specification (OOS) and will require further investigation or corrective actions.
5.7 Post-Testing Actions
- If the batch passes the real-time sampling tests, continue with the next steps in the tablet manufacturing process, such as coating, drying, or packaging.
- If the batch fails, take corrective actions as documented, and re-sample the batch after adjustments to confirm compliance with quality standards.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Uniformity of Dosage Units
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Guidelines for Tablet Manufacturing
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 outside specified range | Adjusted compression pressure and recalibrated tooling | John Doe |
Annexure-2: Batch Record
| Sample Number | Tablet Weight (mg) | Tablet Hardness (kgf) | Tested By |
|---|---|---|---|
| Sample 1 | 600 mg | 8.0 kgf | Jane Smith |
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 sampling intervals and documentation requirements | Improved monitoring process | QA Head |