Procedure for Determining Moisture Content in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for determining the moisture content in granules used in pharmaceutical manufacturing to ensure product stability and quality.

2) Scope

This SOP applies to all granule batches prepared for tablet or capsule production within the manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting moisture content testing and ensuring compliance with this SOP.
Production Department: Responsible for providing granule samples for testing and maintaining granulation process parameters.

4) Procedure

4.1 Sampling:
    4.1.1 Collect representative samples of granules from various points within the granulator according to the sampling plan.
    4.1.2 Ensure samples are taken from different depths and locations to obtain a uniform representation.

4.2 Equipment Preparation:
    4.2.1 Calibrate the moisture analyzer as per the manufacturer’s instructions.
    4.2.2 Ensure the equipment is clean and free from previous residues.

4.3 Moisture Content Determination:
    4.3.1 Weigh an appropriate amount of the granule sample (e.g., 5 grams).
    4.3.2 Place the sample in the moisture analyzer.
    4.3.3 Set the appropriate drying temperature and time (e.g., 105°C for 15 minutes) as per the method specified.
    4.3.4 Start the analysis and allow the equipment to complete the drying process.
    4.3.5 Record the moisture content displayed by the analyzer.

4.4 Calculation:
    4.4.1 The moisture content is calculated automatically by the moisture analyzer based on the weight loss during drying.
    4.4.2 Cross-check the calculated moisture content with manual calculations if necessary.

4.5 Acceptance Criteria:
    4.5.1 The granulation is acceptable if the moisture content is within the specified range (e.g., 2-5%).

4.6 Documentation:
    4.6.1 Document all results and calculations in the Moisture Content Determination Record.
    4.6.2 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Moisture Content Determination Record
Calibration Record for Moisture Analyzer
Sampling Plan Document

7) Reference, if any

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0