Standard Operating Procedure for End-Point Testing During Drying Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/151/2025 |
| Supersedes | SOP/TAB/151/2022 |
| 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 performing end-point testing during the drying process of tablet granules to ensure that they reach the desired moisture content before further processing.
2. Scope
This SOP applies to the drying process of tablet granules, specifically focusing on the testing performed to determine when the granules have reached the optimal moisture content.
3. Responsibilities
- Quality Control (QC): Responsible for performing the end-point testing on granules to verify that the moisture content is within acceptable limits.
- Drying Operator: Responsible for ensuring the drying process is carried out according to the prescribed parameters and for notifying QC when testing is required.
- Quality Assurance (QA): Ensures that end-point testing procedures are followed correctly, reviews test results, and approves corrective actions if necessary.
4. Accountability
The QC Manager is accountable for ensuring that the end-point testing is carried out regularly during the drying process. The QA Manager reviews the test results and approves corrective actions as needed.
5. Procedure
5.1 Sampling
- Collect representative samples of granules from the drying bed or drying equipment at defined intervals during the drying process.
- Ensure that samples are taken from different points within the batch to accurately reflect the moisture content across the entire batch.
5.2 Moisture Content Testing
- Perform moisture content testing on the collected samples using an appropriate method, such as a moisture analyzer or oven-drying method.
- Ensure the test method used is validated for the specific granules being tested.
- Test moisture content at least twice per batch or as per established sampling plan.
5.3 End-Point Determination
- Compare the results of the moisture content testing to the acceptable moisture content range for the granules. This range should be predefined based on the formulation requirements.
- The batch is considered dried when the moisture content falls within the specified range, typically between 2-5% for most tablet formulations.
- If the moisture content is outside the acceptable range, the granules should be returned to the dryer for further drying, and additional testing should be conducted.
5.4 Documentation
- Document the results of the moisture content testing in the batch record (Annexure-2), including the moisture content percentage, the sampling time, and the method used for testing.
- Note any deviations or corrective actions taken, such as further drying if the moisture content is too high.
5.5 Corrective Actions
- If the moisture content is found to be outside the acceptable limits, initiate corrective actions such as adjusting the drying time, temperature, or airflow in the drying equipment.
- After corrective actions are taken, perform further testing to verify that the moisture content falls within the acceptable range before proceeding with tablet compression.
5.6 Post-Testing Actions
- If the batch passes the end-point testing and meets the desired moisture content, proceed with further tablet manufacturing steps, such as granulation or compression.
- If the batch fails, perform a root cause analysis, modify the drying process, and re-test until the correct moisture content is achieved.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- Moisture Content: The amount of water present in the granules, typically expressed as a percentage of the total weight.
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Moisture Testing for Granules
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Guidelines for Moisture Testing
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 | Moisture content exceeded the required range | Adjusted drying parameters and re-dried the batch | John Doe |
Annexure-2: Batch Record
| Sample Number | Moisture Content | Action Taken |
|---|---|---|
| Sample 1 | 3.0% | 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 testing procedure | Improved compliance | QA Head |