What should be included in the quality control processes for compounded preparations?

In quality control processes for compounded preparations, it is essential to include testing for sterility, potency, and stability. This comprehensive approach ensures that the compounded products are safe, effective, and reliable for patient use.

Sterility testing is critical because compounded preparations must be free from microorganisms that could pose serious risks to patients. Potency testing confirms that the preparation contains the active ingredients in the correct amounts to ensure therapeutic efficacy. Stability testing assesses how long the compounded product maintains its quality and effectiveness under specific conditions, thereby determining an appropriate shelf life.

By addressing all three aspects—sterility, potency, and stability—quality control processes can better ensure that compounded preparations meet regulatory standards and provide the intended clinical benefits, significantly reducing the risk of patient harm associated with poorly compounded products. This holistic approach to quality control is fundamental to maintaining high standards in compounding practices.