Moisture Content Monitoring and Control Procedures

1) Purpose

The purpose of this SOP is to establish a standardized procedure for monitoring and controlling moisture levels in capsules to ensure product stability and proper dissolution.

2) Scope

This SOP applies to all capsules produced and stored within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting moisture content tests on capsules.
– Production personnel must provide samples of capsules for testing.
– QA personnel are responsible for reviewing and approving the test results.

4) Procedure

1. Sample Collection
1.1. Collect representative samples of capsules from each batch.
1.2. Ensure samples are collected at regular intervals during production and storage.
1.3. Label each sample with batch number, date, and time of collection.
2. Moisture Content Analysis
2.1. Use a moisture analyzer or loss on drying (LOD) method to determine the moisture content of the capsules.
2.2. Weigh a sample of capsules and place it in the moisture analyzer.
2.3. Follow the manufacturer’s instructions for operating the moisture analyzer.
2.4. Record the moisture content results and ensure they are within the acceptable range.
3. Control Measures
3.1. If moisture content is above the specified range, implement control measures such as drying the capsules or adjusting storage conditions.
3.2. Ensure that capsules are stored in environments with controlled humidity to prevent moisture uptake.
3.3. Use desiccants in storage containers to maintain low humidity levels.
4. Documentation
4.1. Record all moisture content test results on the moisture content control form.
4.2. Include details such as batch number, date of testing, moisture content values, and any observations or anomalies.
4.3. Sign and date the control form.
5. Review and Approval
5.1. Submit the completed control forms to the QA department for review.
5.2. QA will review and approve the results based on the criteria outlined in this SOP.
6. Corrective Actions
6.1. If the moisture content does not meet the specified criteria, initiate a corrective action report.
6.2. Document all actions taken to address issues identified during the testing, including potential re-drying or adjustments to storage conditions.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– LOD: Loss on Drying

6) Documents, if any

– Moisture Content Control Form
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– USP <921> Water Determination

8) SOP Version

Version 1.0