Procedures for Measuring and Controlling Moisture Content in Capsules

1) Purpose

The purpose of this SOP is to provide procedures for measuring and controlling the moisture content of capsules, especially for hygroscopic formulations, to ensure product stability and quality.

2) Scope

This SOP applies to all capsules manufactured within the pharmaceutical facility, particularly those containing hygroscopic formulations.

3) Responsibilities

The Production and Quality Control (QC) departments are responsible for measuring and controlling the moisture content of capsules.

4) Procedure

1. Preparation for Moisture Content Testing:
   1. Ensure all moisture analyzers are calibrated and clean.
   2. Prepare the samples for moisture content testing according to the batch record instructions.
   3. Label and document the samples for traceability.
2. Measuring Moisture Content:
   1. Load the capsule samples into the moisture analyzer according to the manufacturer’s instructions.
   2. Set the analyzer parameters (e.g., temperature, time) as specified in the test method.
   3. Start the analysis and monitor the process until completion.
   4. Record the moisture content results for each sample in the moisture content logbook.
3. Interpreting Results:
   1. Compare the recorded moisture content results to the established acceptance criteria.
   2. Document any instances where the moisture content exceeds the acceptable limits.
   3. Investigate any out-of-specification results and determine the root cause.
4. Controlling Moisture Content:
   1. Implement corrective actions for batches with out-of-specification moisture content.
   2. Adjust environmental controls, such as humidity levels in storage and production areas, to prevent moisture content deviations.
   3. Use appropriate desiccants or moisture control packaging materials for hygroscopic formulations.
5. Documentation and Review:
   1. Maintain records of all moisture content tests in the moisture content logbook.
   2. Review and approve the test results and any corrective actions taken.
   3. Conduct periodic reviews of moisture content data to ensure ongoing compliance and product quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Moisture Content Logbook, Calibration Records, and Corrective Action Reports

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0