Criteria for Determining Acceptable Moisture Content Levels in Capsules

1) Purpose

The purpose of this SOP is to establish the criteria for determining acceptable moisture content levels in capsules 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 Quality Control (QC) department is responsible for setting and verifying the acceptance criteria for moisture content levels.

4) Procedure

1. Establishing Acceptance Criteria:
   1. Determine the acceptable moisture content range based on the product’s formulation and stability studies.
   2. Consult relevant regulatory guidelines and industry standards to set the moisture content limits.
   3. Document the established acceptance criteria in the product specification document.
2. Verifying Acceptance Criteria:
   1. Periodically review and verify the moisture content acceptance criteria based on ongoing stability data and product performance.
   2. Update the acceptance criteria as necessary to ensure continued product quality and compliance.
3. Testing and Documentation:
   1. Conduct moisture content tests on each batch of capsules according to the established testing procedure.
   2. Compare the test results to the documented acceptance criteria.
   3. Record the test results and any deviations in the moisture content logbook.
4. Handling Deviations:
   1. If any test results fall outside the acceptable moisture content range, document the deviation and investigate the cause.
   2. Implement corrective actions to address the deviation and prevent recurrence.
   3. Document the investigation and corrective actions in the deviation report.
5. Review and Approval:
   1. The QC manager or designee must review and approve all moisture content test results and any deviations.
   2. Ensure that all corrective actions are properly implemented and documented before final approval.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Moisture Content Logbook, Deviation Reports, and Product Specification Documents

7) Reference, if any

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

8) SOP Version

Version 1.0