RXQ’s Compounded Sterile Product Testing Procedure to Ensure Safety and Quality
As an FDA registered 503B Outsourcing Facility, all compounded sterile products manufactured by RXQ Compounding are required to be finished product tested. Finished product testing is completed to ensure the safety and quality of the final product and to conform to federal regulations.
Each batch of finished compounded sterile product manufactured at RXQ is subject to in-house inspection, third-party contractor testing, and Quality Assurance review prior to being released and sold. Each sterile product has a Finished Product Specification created by RXQ to ensure the quality of the drug product. The Finished Product Specification is created using the applicable USP monograph, which “articulates the quality expectations for a medicine including for its identity, strength, purity and performance” (USP.org). Finished Product Specifications also include test procedures and their acceptance criteria that the finished product must comply with at the time of its release and through its valid shelf life. Finished compounded sterile product testing starts after product manufacturing is complete at our state-of-the-art facility.
After the manufacturing process is finished, in-house testing is completed by the RXQ Operations and Quality Units.
RXQ’s Operations Unit completes visual inspection as part of finished product, in-house testing. Visual inspection entails inspecting vials for container closure defects, outside visual defects, and possible foreign material in the vial solution. Once the inspection is completed, any defects found are recorded and the defective vials are placed into designated baskets and disposed.
Next, RXQ’s Quality Unit completes a second visual inspection of a portion of the lot, and a final review of the finished product. This review ensures that all final compounded sterile product vials are sealed, labeled, and counted properly.
At the conclusion of all in-house testing procedures, the finished compounded sterile product is placed into RXQ’s Quarantine area. The product waits in Quarantine during third-party testing and Quality Unit review.
Third-Party Contractor Testing
Once in-house testing is completed, a predetermined quantity of the finished product is sent to an approved third-party contractor for additional testing. This quantity is based on the type of product and the product specific specification required for testing.
Once received by the testing contractor, the following tests are completed on the finished product:
- Sterility (USP <71>)
- Bacterial Endotoxin (USP <85>)
Third-party, end-product testing is completed in compliance with FDA requirements.
Quality Assurance Review
Once third-party, end-product testing is complete, the results are sent to RXQ’s Quality Unit. The results are then subject to another Quality Unit review. During this review, the results are verified against the product specification acceptance criteria. The finished product is not released from Quarantine until all testing results pass within specifications set by RXQ’s Quality Unit.
After all finished product testing is complete and testing results are satisfactory, the compounded sterile product is released by the Quality unit and is available to be purchased and shipped. The Safety and Quality of our compounded sterile product is very important to RXQ. Above all, RXQ is committed to providing our customers with high quality, safe product approved for in-office use.
To guarantee safety, availability, and compliance, make RXQ your preferred 503B Outsourcing Facility by contacting us today!