Standard Operating Procedure for Dissolution Testing of Capsules

Department	Capsule Manufacturing
SOP No.	SOP/CM/189/2025
Supersedes	SOP/CM/189/2022
Page No.	Page 1 of 9
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This SOP defines the procedure for performing dissolution testing of capsules to ensure that the release of active pharmaceutical ingredients (APIs) from capsules meets the required specifications under defined conditions.

2. Scope

This SOP applies to all soft and hard gelatin capsules that require dissolution testing to verify that the capsules release the drug substance in a controlled and predictable manner.

3. Responsibilities

• Quality Control (QC) Team: Responsible for performing dissolution testing on capsule samples, ensuring that all procedures are followed accurately and results are documented appropriately.
• Quality Assurance (QA) Team: Ensures that the dissolution testing process complies with applicable regulatory guidelines and approves or rejects capsules based on test results.
• Production Team: Provides the required capsule samples for dissolution testing and ensures proper handling during the sampling process.

4. Accountability

The QA Manager is responsible for ensuring that the dissolution testing process adheres to regulatory and company standards. The QC Supervisor is responsible for the execution of dissolution testing and ensuring that the results are accurate and compliant with specifications. The Production Supervisor ensures that the required samples are provided for testing in a timely manner.

5. Procedure

5.1 Pre-Testing Setup

Before starting the dissolution test, ensure the following:

1. Review Testing Criteria
   1. Review the dissolution specifications for the capsules based on the regulatory guidelines (e.g., USP, EP). These limits must be approved by the QA department before testing.
2. Prepare Testing Equipment
   1. Ensure the dissolution apparatus is calibrated and the temperature of the dissolution medium is maintained at 37°C ± 0.5°C.
   2. Ensure that all dissolution equipment, such as paddles or baskets, are in good condition and properly installed.
3. Prepare Sample Collection
   1. Collect a representative sample of capsules, typically 6 capsules, from the batch. The sample should be selected randomly to ensure it is representative of the entire batch.

5.2 Dissolution Testing Procedure

Follow these steps to perform the dissolution test:

1. Prepare Dissolution Apparatus
   1. Place the appropriate number of capsules (typically 6 capsules) in the dissolution apparatus, ensuring they are correctly positioned and the medium volume is correct (usually 900 mL of the dissolution medium).
2. Initiate Testing
   1. Set the dissolution apparatus to the appropriate speed, typically 50-75 rpm, and begin the test. The dissolution medium should maintain the specified temperature (37°C ± 0.5°C).
3. Monitor Dissolution Process
   1. At specified time intervals, withdraw samples of the dissolution medium, typically at 15, 30, 45, and 60 minutes, and analyze for the released API.
4. Document Results
   1. Record the cumulative percentage of drug released at each time interval. Compare the results with the acceptance criteria (e.g., 80% API release in 30 minutes).

5.3 Post-Testing Activities

After the dissolution test is completed, ensure the following:

1. Review Results
   1. The QA Manager reviews the dissolution test results to ensure that the capsules meet the specified release criteria. If any capsule fails to meet the specifications, initiate an investigation.
2. Corrective Actions
   1. If any capsule fails the dissolution test, the root cause should be investigated, which could include reviewing the formulation, the manufacturing process, or the quality of raw materials used. Appropriate corrective actions should be implemented.
3. Training and Feedback
   1. If discrepancies are identified during testing, provide feedback to operators and provide training as necessary to ensure correct procedures are followed.
4. Record Keeping
   1. Ensure that all records related to dissolution testing, including the test logs, results, and corrective actions, are properly filed and archived in compliance with 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
• API: Active Pharmaceutical Ingredient
• rpm: Revolutions Per Minute

7. Documents

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

8. References

• USP <711> – Dissolution Test
• European Pharmacopoeia 2.9.3 – Dissolution Test for Capsules
• 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
Dissolution Apparatus 105	01/02/2025	John Doe	Calibration of dissolution speed and temperature	01/02/2026

Annexure 2: Dissolution Testing Log

Capsule ID	Test Date	Test Time (min)	Release (%)	Acceptance Criteria	Result
Batch 003	02/02/2025	30	95%	≥ 85% released in 30 minutes	Pass

Annexure 3: Corrective Action Report

Batch ID	Deviation	Corrective Action	Responsible Person	Completion Date
Batch 003	API release failure	Adjustment of capsule filling process	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 dissolution testing of capsules	QA Head
01/02/2025	2.0	Updated dissolution method and record format	Improved testing procedure and compliance	QA Head