Standard Operating Procedure for Moisture Content Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for determining the moisture content of granule formulations in the pharmaceutical industry to ensure product quality and stability.

2) Scope

This SOP applies to all personnel involved in moisture content testing of granule formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

Analytical Chemist: Responsible for performing moisture content testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the moisture content testing procedure and results.

4) Procedure

1. Sample Collection:
   1. Select representative samples from different batches or lots according to the sampling plan.
   2. Ensure samples are homogeneous and free from external moisture contamination.
2. Sample Preparation:
   1. Weigh the sample accurately using a calibrated balance.
   2. If necessary, dry the sample in an oven under specified conditions to remove moisture before testing.
3. Testing:
   1. Transfer the prepared sample to the moisture analyzer.
   2. Set the analyzer to the appropriate parameters (e.g., temperature, drying time).
   3. Initiate the moisture determination process and allow the analyzer to complete the measurement.
4. Measurement:
   1. Record the moisture content percentage displayed by the analyzer.
   2. If required, perform calculations to adjust for any sample weight changes during drying.
5. Reporting:
   1. Document the moisture content test results in the appropriate logbook or electronic system.
   2. Include any deviations noted during testing and actions taken.
6. Documentation:
   1. Maintain accurate records of all moisture content testing activities, including raw data, calculations, and reports.
   2. File documentation in accordance with Good Documentation Practices (GDP).

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
GDP: Good Documentation Practices

6) Documents, if any

Moisture Content Testing Protocol, Test Results, Moisture Content Report

7) Reference, if any

Pharmacopeial guidelines for moisture content testing of pharmaceutical granules.

8) SOP Version

Version 1.0