SOP Guide for Pharma

Tablets: SOP for Monitoring Humidity During Tablet Packing – V 2.0

Auditor

Tablets: SOP for Monitoring Humidity During Tablet Packing – V 2.0

Standard Operating Procedure for Monitoring Humidity During Tablet Packing

Department Tablet
SOP No. SOP/TAB/234/2025
Supersedes SOP/TAB/234/2022
Page No. Page 1 of 5
Issue Date 01/04/2026
Effective Date 06/04/2026
Review Date 01/04/2027

1. Purpose

This SOP describes the process for monitoring and controlling humidity levels during tablet packing to ensure the integrity of the packed product. Proper humidity control during packing ensures that the tablets do not degrade, preventing issues such as moisture-related defects or packaging failure.

2. Scope

This SOP applies to all tablet packing operations where humidity control is critical to product quality. It covers the monitoring of humidity levels in packing areas, ensuring that they remain within specified limits to avoid damage to the tablets.

3. Responsibilities

  • Production Manager: Oversees humidity monitoring during the packing process and ensures compliance with this SOP.
  • Packing Line Operator: Monitors the humidity levels in the packing area, reports any discrepancies, and takes corrective action when necessary.
  • Quality Control (QC) Personnel: Ensures that humidity levels are measured correctly and consistently, and reviews records to verify compliance.
  • Maintenance Personnel: Ensures that humidity control equipment such as dehumidifiers, HVAC systems, and humidity sensors are functional and calibrated.
See also  Tablets: SOP for Monitoring Critical Process Parameters (CPPs) - V 2.0

4.

Accountability

The Production Manager is accountable for ensuring that the humidity levels during the tablet packing process are properly monitored and maintained. The QC department is responsible for verifying humidity levels and ensuring that all readings are documented and comply with the specifications.

5. Procedure

5.1 Humidity Monitoring Setup

  1. Ensure that humidity sensors are calibrated and positioned in critical areas of the packing room, such as near tablet storage areas and packing stations (Annexure-1).
  2. Check the HVAC systems and dehumidifiers to ensure they are functioning correctly and maintaining the required environmental conditions (Annexure-2).
  3. Verify that the environmental control systems are set to the specified humidity range for tablet packing (30%–50%) (Annexure-3).
  4. Perform a pre-packing environmental check to ensure that all equipment and systems are operating within the correct parameters (Annexure-4).

5.2 Monitoring Humidity During Packing

  1. Monitor the humidity levels every 30 minutes during the tablet packing process and log the readings (Annexure-5).
  2. If humidity levels fall outside the acceptable range, notify the Production Manager and take corrective action immediately, such as adjusting the HVAC system or dehumidifiers (Annexure-6).
  3. Record any adjustments made to the environment in the humidity control log (Annexure-7).
  4. Ensure that all personnel involved in the packing process are aware of the importance of maintaining the correct humidity levels for product integrity (Annexure-8).

5.3 Corrective Actions

  1. If humidity levels fall outside the specified range for more than 15 minutes, stop the packing process and inspect all affected product batches (Annexure-9).
  2. Conduct an investigation to determine the root cause of the humidity deviation (e.g., HVAC malfunction, external environmental factors) (Annexure-10).
  3. Take appropriate corrective actions, such as adjusting equipment settings or repairing faulty systems (Annexure-11).
  4. In case of any product defect, notify the QA department, and perform a product re-inspection (Annexure-12).

5.4 End-of-Line Monitoring and Documentation

  1. At the end of the packing process, review the humidity logs to ensure all readings are within the specified range (Annexure-13).
  2. Ensure that the packing line is cleaned and reset to maintain optimal humidity conditions for the next batch (Annexure-14).
  3. Ensure that all corrective actions, if any, are documented and reviewed by QA (Annexure-15).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practice
  • HVAC: Heating, Ventilation, and Air Conditioning
  • QC: Quality Control

7. Documents

  1. Humidity Control Log (Annexure-5)
  2. Calibration Records for Humidity Sensors (Annexure-1)
  3. HVAC and Dehumidifier Maintenance Logs (Annexure-2)
  4. Environmental Control System Settings (Annexure-3)
  5. Pre-Packing Environmental Check Log (Annexure-4)
  6. Humidity Monitoring Log (Annexure-6)
  7. Corrective Action Log (Annexure-7)
  8. Product Inspection Log (Annexure-8)
  9. Root Cause Analysis Report (Annexure-10)
  10. Product Re-Inspection Log (Annexure-12)
  11. Final Humidity Check Log (Annexure-13)
  12. End-of-Line Reset Log (Annexure-14)
  13. Corrective Action Review Log (Annexure-15)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • USP <1079> – Good Storage and Distribution Practices

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Calibration Records for Humidity Sensors

Sensor ID Calibration Date Calibrated By Next Calibration Due
HS-001 01/04/2026 John Doe 01/04/2027

Annexure-2: HVAC and Dehumidifier Maintenance Logs

Equipment Maintenance Date Performed By Action Taken
HVAC System 01/04/2026 Jane Smith Filter replacement, system cleaning

Annexure-3: Environmental Control System Settings

System Setting Operator
HVAC Temperature: 22°C, Humidity: 40% John Doe
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