Guidelines for Determining Acceptable Moisture Content in Capsules

1) Purpose

The purpose of this SOP is to establish the acceptance criteria for moisture content levels in capsules to ensure product quality and stability.

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 establishing and maintaining the acceptance criteria for moisture content. The Production department is responsible for adhering to these criteria during manufacturing.

4) Procedure

1. Establishing Moisture Content Criteria:
   1. Determine the acceptable range for moisture content based on product specifications, stability data, and regulatory guidelines.
   2. Document the moisture content criteria in the product specification sheet.
2. Testing for Moisture Content:
   1. Conduct moisture content tests as outlined in the moisture content control procedure.
   2. Compare the measured moisture content of each capsule to the established criteria.
3. 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.
4. Documentation and Review:
   1. Record all test results and any deviations in the moisture content logbook.
   2. Periodically review the moisture content criteria and update as necessary to ensure ongoing compliance and quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Product Specification Sheet, Moisture Content Logbook, Deviation Reports, and Corrective
Action Records

7) Reference, if any

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

8) SOP Version

Version 1.0