Guidelines for Measuring and Controlling Moisture Content in Capsules

1) Purpose

The purpose of this SOP is to provide guidelines for measuring and controlling the moisture content of capsules, which is especially important for hygroscopic formulations.

2) Scope

This SOP applies to all capsules produced within the pharmaceutical manufacturing facility that require moisture content control.

3) Responsibilities

The Quality Control (QC) department is responsible for measuring moisture content and ensuring it meets the specified acceptance criteria. The Production department is responsible for controlling moisture content during manufacturing.

4) Procedure

1. Preparation for Moisture Content Measurement:
   1. Ensure all moisture analyzers and related equipment are calibrated and clean before use.
   2. Prepare the capsules to be tested according to the test method requirements.
2. Measuring Moisture Content:
   1. Select a representative sample of capsules from the batch to be tested.
   2. Weigh the capsules and place them in the moisture analyzer.
   3. Follow the equipment instructions to measure the moisture content accurately.
   4. Record the moisture content results for each capsule in the moisture content logbook.
3. Controlling Moisture Content:
   1. Maintain appropriate environmental controls in the manufacturing and storage areas to minimize moisture uptake.
   2. Use desiccants or other moisture control measures as necessary during storage and transport.
4. Handling Out-of-Specification Results:
   1. If the moisture content of any capsule is found to be outside the acceptable range, document the deviation and investigate the cause.
   2. Implement corrective actions to address the deviation and prevent recurrence.
   3. Re-test the capsules after corrective actions to ensure compliance with the moisture content criteria.
5. Documentation and Review:
   1. Record all moisture content results and any deviations in the moisture content logbook.
   2. Periodically review the moisture content control procedures and acceptance criteria, updating as necessary to ensure ongoing compliance and quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Moisture Content Logbook, Test Methods, and Calibration Records

7) Reference, if any

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

8) SOP Version

Version 1.0