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