Standard Operating Procedure for Disintegration Testing

Purpose

The purpose of this SOP is to establish procedures for the systematic and accurate testing of disintegration time in pharmaceutical products, ensuring compliance with regulatory standards and maintaining product quality.

Scope

This SOP applies to all personnel involved in the disintegration testing process, including laboratory technicians and quality control personnel.

Responsibilities

• Laboratory Technicians: Responsible for conducting disintegration testing following established procedures.
• Quality Control Personnel: Responsible for reviewing and approving disintegration testing results for compliance.

Procedure

1. Inspect the disintegration testing apparatus for any visible damage or defects before each use.
2. Ensure that the equipment is clean, calibrated, and properly set up for the specific testing method to be employed.
3. Prepare the samples to be tested according to the approved sampling plan, ensuring they are representative of the batch.
4. Load the samples into the disintegration testing apparatus, following the instrument-specific loading procedure.
5. Run the disintegration testing according to the established method, specifying parameters such as testing duration and temperature.
6. Monitor the apparatus during the testing process, ensuring that samples disintegrate within the predefined time frame.
7. Record the disintegration testing results, including disintegration time for each sample, in the designated logbook or electronic system.
8. If adjustments to the testing parameters are necessary, document the changes made and the reason for the adjustments.
9. Perform routine checks and calibrations of the disintegration testing apparatus to ensure accurate and reliable results.
10. Perform validation checks if required for the specific disintegration testing method being used.
11. Review the disintegration testing results for compliance with predefined specifications and acceptance criteria.
12. Document any out-of-specification (OOS) results, initiate an investigation, and implement corrective actions as needed.
13. Archive disintegration testing records in accordance with established retention policies.
14. Regularly review and update the disintegration testing method as needed based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Disintegration Testing Logbook
• Calibration Records
• Validation Reports
• Deviation and Corrective Action Logs

Reference

USP General Chapter <701> – Disintegration

SOP Version

Version 1.0