Standard Operating Procedure for Moisture Content Determination

1) Purpose

This SOP outlines the procedures for determining the moisture content of pharmaceutical raw materials and products.

2) Scope

This SOP applies to moisture content determination of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing moisture content determination. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the moisture content determination protocol and ensure all necessary materials and equipment are available (e.g., moisture analyzer).
2. Verify the calibration and functionality of the moisture analyzer.

4.2 Sample Collection and Preparation

1. Collect representative samples of raw materials or products according to sampling procedures.
2. Prepare the samples by ensuring they are homogenized and free from external moisture.
3. Weigh the samples accurately.

4.3 Testing Procedure

1. Place the prepared samples in the moisture analyzer and initiate the moisture determination process.
2. Record the moisture content reading provided by the analyzer.
3. Perform the moisture determination in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the moisture content of the tested samples meets the specified acceptance criteria based on compendial standards or product specifications.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a moisture content determination report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Moisture Content Determination Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <921> Water Determination, European Pharmacopoeia (Ph. Eur.) 2.5.12 Determination of Water by Karl Fischer Titration

8) SOP Version

Version 1.0