Standard Operating Procedure for Humidity Monitoring During Tablet Manufacturing
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/161/2025 |
| Supersedes | SOP/TAB/161/2022 |
| 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 monitoring and controlling humidity levels during tablet manufacturing, ensuring that the tablets are produced under optimal environmental conditions to maintain product quality.
2. Scope
This SOP applies to the tablet manufacturing process, specifically focusing on the control and monitoring of humidity levels in production areas to ensure compliance with GMP guidelines and product specifications.
3. Responsibilities
- Quality Control (QC): Responsible for monitoring the humidity levels in the manufacturing area and ensuring compliance with specified limits. QC also verifies that all humidity readings are documented.
- Production Operator: Responsible for ensuring that the humidity levels in the manufacturing areas are within specified limits during tablet production and notifying QC if any readings are outside acceptable ranges.
- Quality Assurance (QA): Ensures that the humidity monitoring process is followed according to this SOP and that corrective actions are taken when necessary.
4. Accountability
The Production Supervisor is accountable for ensuring that the humidity levels in the tablet manufacturing areas are monitored consistently. The QC Manager ensures that humidity monitoring devices are calibrated and functioning as expected. The QA Manager ensures that the process is compliant with this SOP.
5. Procedure
5.1 Preparation for Humidity Monitoring
- Ensure that all humidity monitoring devices, such as hygrometers or humidity sensors, are calibrated and functioning correctly.
- Confirm that the manufacturing areas are properly set up for tablet production, including appropriate airflow, temperature, and humidity control systems.
- Verify that the environmental conditions (temperature and humidity) are within the acceptable limits specified in the batch record or product specifications.
5.2 Monitoring Humidity Levels
- Monitor the humidity levels at regular intervals during tablet manufacturing, particularly during critical steps such as blending, granulation, and drying.
- Record the humidity levels at specified intervals (e.g., every 2 hours) in the batch record (Annexure-2), including the time, date, and location of the reading.
- Ensure that humidity levels remain within the specified range, typically between 40% and 60% relative humidity (RH) for most tablet manufacturing processes.
- If automated humidity monitoring systems are in place, verify that the systems are functioning properly and that data logs are being captured automatically.
5.3 Adjusting Humidity Levels
- If humidity levels are found to be outside the specified range, take immediate corrective action. Adjust the air conditioning, dehumidifiers, or humidifiers as necessary to bring the humidity levels back within the acceptable limits.
- If manual adjustments are required, verify the settings and functionality of the HVAC systems and environmental controls in the manufacturing area.
- Notify the QC and QA teams about the deviation and ensure that corrective actions are documented in the deviation report (Annexure-1).
5.4 Documentation of Humidity Levels
- Document all humidity readings in the batch record (Annexure-2), including any corrective actions taken to address deviations in humidity levels.
- Ensure that the recorded humidity levels are reviewed periodically by the QA team for compliance with product specifications.
- Keep records of humidity monitoring for the required retention period, as specified in the company’s document retention policy.
5.5 Corrective Actions for Humidity Deviations
- If humidity levels exceed the specified range for a prolonged period, investigate the root cause. Potential causes may include malfunctioning HVAC systems, insufficient ventilation, or improper room setup.
- Adjust the manufacturing environment, equipment settings, or process parameters to maintain optimal humidity levels.
- If a significant deviation occurs, initiate a deviation report (Annexure-1) and review the batch for any potential impact on tablet quality.
- Take corrective actions to prevent future deviations, including equipment calibration, process adjustments, or procedural updates.
5.6 Acceptance Criteria
- The batch is considered acceptable if the humidity levels in the manufacturing area remain within the specified range (typically 40% to 60% RH) during the critical phases of tablet production.
- If deviations occur but corrective actions bring the humidity back within the acceptable range, the batch may still be accepted, provided there is no adverse impact on tablet quality.
- If humidity levels remain outside the acceptable range for an extended period, initiate a full investigation and corrective action, which may include rework or rejection of the batch.
5.7 Post-Testing Actions
- After the humidity levels have been adjusted and are within the acceptable range, continue with the next step in the tablet manufacturing process, such as drying, compression, or coating.
- Ensure that all documentation is complete, including batch records, humidity logs, and corrective actions taken during the process.
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> – Humidity Control Guidelines
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Environmental Control Standards for 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 | Humidity levels exceeded the acceptable range | Adjusted HVAC settings and re-calibrated environmental controls | John Doe |
Annexure-2: Batch Record
| Time | Humidity Level (%) | Temperature (°C) | Action Taken |
|---|---|---|---|
| 08:00 AM | 50% | 22°C | No action needed |
| 12:00 PM | 65% | 22°C | Adjusted dehumidifiers |
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 humidity monitoring criteria | Improved control and documentation processes | QA Head |