Standard Operating Procedure for Content Uniformity Testing

Purpose

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

Scope

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

Responsibilities

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

Procedure

1. Inspect the content uniformity testing equipment 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 sample to be tested according to the approved sampling plan, ensuring it is representative and homogenous.
4. Load the sample into the content uniformity testing equipment, following the instrument-specific loading procedure.
5. Run the content uniformity testing according to the established method, specifying parameters such as sample size and testing duration.
6. Monitor the instrument during the testing process, addressing any issues or deviations promptly.
7. Record the content uniformity testing results, including individual assay values and any other relevant data, 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 content uniformity testing equipment to ensure accurate and reliable results.
10. Perform validation checks if required for the specific content uniformity testing method being used.
11. Review the content uniformity 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 content uniformity testing records in accordance with established retention policies.
14. Regularly review and update the content uniformity testing method as needed based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

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

Reference

USP General Chapter <905> – Uniformity of Dosage Units

SOP Version

Version 1.0