Standard Operating Procedure for Moisture Content Testing of Capsules

Department	Capsule Manufacturing
SOP No.	SOP/CM/191/2025
Supersedes	SOP/CM/191/2022
Page No.	Page 1 of 8
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This SOP outlines the procedure for determining the moisture content of capsules to ensure that the capsules are within the acceptable moisture range, which is crucial for the stability and quality of the capsules.

2. Scope

This SOP applies to all capsules manufactured at the facility that require moisture content testing to confirm that they meet specified limits for stability and performance.

3. Responsibilities

• Quality Control (QC) Team: Responsible for conducting moisture content testing on capsule samples and documenting the results as per the testing requirements.
• Quality Assurance (QA) Team: Ensures compliance with the moisture content specifications and approves or rejects capsules based on the test results.
• Production Team: Provides the necessary capsule samples for moisture content testing and ensures proper handling during sampling.

4. Accountability

The QA Manager is responsible for ensuring that the moisture content testing process follows GMP and regulatory standards. The QC Supervisor ensures the accurate execution of the testing and documentation. The Production Supervisor ensures timely sample provision for testing.

5. Procedure

5.1 Pre-Testing Setup

Before beginning the moisture content testing, ensure the following:

1. Review Testing Criteria
   1. Review the moisture content specifications for the capsules based on regulatory guidelines (e.g., USP, EP). These limits must be approved by the QA department before testing.
2. Prepare Testing Equipment
   1. Ensure that the moisture balance or oven used for testing is calibrated and functioning correctly. Verify that the drying temperature is set to the correct value, typically 105°C for moisture content determination using an oven.
3. Prepare Sample Collection
   1. Collect a representative sample of capsules, typically 10-20 capsules, from the batch. Ensure the sample is randomly selected to represent the entire batch.

5.2 Moisture Content Testing Procedure

Follow these steps to perform the moisture content test:

1. Weigh the Capsules Before Testing
   1. Weigh the sample of capsules before placing them in the moisture content testing apparatus or oven using an analytical balance. Record the weight as the initial weight.
2. Test the Moisture Content
   1. Place the capsules in the moisture balance or oven. For oven testing, set the temperature to 105°C, and dry the capsules until a constant weight is achieved (usually after 3 hours or as per specifications).
   2. For moisture balance testing, ensure the sample is placed in the balance, and the moisture reading is taken after the drying process is completed.
3. Record Results
   1. Calculate the percentage of moisture content based on the difference in the initial weight and final weight after drying.
   2. Record the moisture content value and compare it with the established specifications (e.g., <1% or <5% moisture depending on the product).

5.3 Post-Testing Activities

After completing the moisture content test, ensure the following:

1. Review Results
   1. The QA Manager reviews the moisture content results to ensure that the capsules meet the specified criteria. If any capsule fails the test, initiate an investigation to identify the cause.
2. Corrective Actions
   1. If capsules fail the moisture content test, investigate the potential causes (e.g., improper storage, formulation issues). Implement corrective actions as necessary, such as adjusting the drying process or modifying the formulation.
3. Training and Feedback
   1. If any discrepancies are identified during testing, provide feedback to the testing team and offer additional training to improve adherence to procedures.
4. Record Keeping
   1. Ensure that all records related to moisture content testing, including test logs, results, and corrective actions, are filed and archived according to regulatory requirements.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• USP: United States Pharmacopeia
• EP: European Pharmacopeia
• RSD: Relative Standard Deviation

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Moisture Content Testing Log
3. Annexure 3: Corrective Action Report

8. References

• USP <731> – Loss on Drying
• European Pharmacopoeia 2.5.32 – Determination of Moisture Content
• Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Moisture Balance 108	01/02/2025	Jane Doe	Calibration of temperature and weight measurements	01/02/2026

Annexure 2: Moisture Content Testing Log

Capsule ID	Test Date	Initial Weight (g)	Final Weight (g)	Moisture Content (%)	Result
Batch 005	02/02/2025	0.750	0.740	1.33%	Pass

Annexure 3: Corrective Action Report

Batch ID	Deviation	Corrective Action	Responsible Person	Completion Date
Batch 005	Excess moisture content	Adjust drying process and optimize capsule formulation	Production Supervisor	03/02/2025

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for moisture content testing	QA Head
01/02/2025	2.0	Updated testing procedure and log format	Improvement of testing accuracy and compliance	QA Head