Standard Operating Procedure for Moisture Content Control

Purpose

The purpose of this SOP is to establish procedures for the systematic control and monitoring of moisture content in pharmaceutical products, ensuring compliance with regulatory standards and maintaining product quality.

Scope

This SOP applies to all personnel involved in the manufacturing, testing, and quality control of pharmaceutical products, specifically those responsible for processes affected by moisture content.

Responsibilities

• Operators: Responsible for executing procedures to control moisture content during manufacturing processes.
• Quality Control Personnel: Responsible for monitoring and verifying moisture content in finished products.
• Technical Staff: Responsible for maintaining and calibrating equipment used in moisture content control.

Procedure

1. Inspect moisture control equipment for any visible damage or defects before each use.
2. Ensure that equipment is clean, calibrated, and properly set up for the specific testing method or manufacturing process.
3. Verify the accuracy of moisture analysis equipment by using calibrated reference standards.
4. Calibrate moisture analysis equipment at regular intervals according to the approved calibration schedule.
5. During manufacturing, implement controls to minimize exposure of materials to ambient moisture, especially in critical processing steps.
6. For products susceptible to moisture, establish and monitor environmental controls such as humidity levels in manufacturing areas.
7. For finished products, conduct moisture content testing according to approved testing procedures.
8. Record moisture content testing results, ensuring proper documentation of the method used, equipment settings, and environmental conditions.
9. Ensure that the moisture content of finished products is within the specified acceptance criteria.
10. If adjustments to the manufacturing process or testing parameters are necessary, document the changes made and the reason for the adjustments.
11. Perform routine checks and calibrations of moisture analysis equipment to ensure accurate and reliable results.
12. Perform validation checks if required for the specific moisture analysis method being used.
13. Document any out-of-specification (OOS) results, initiate an investigation, and implement corrective actions as needed.
14. Archive moisture content control records in accordance with established retention policies.
15. Regularly review and update moisture content control procedures based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Moisture Content Control Logbook
• Calibration Records
• Validation Reports
• Deviation and Corrective Action Logs

Reference

USP General Chapter <921> – Water Determination

SOP Version

Version 1.0