In the highly-regulated pharmaceutical, medical devices, and clinical industries, even tiny inconsistencies can compound to serious issues without the proper qualification and validation protocols in place.
As a component of quality assurance, equipment validation is absolutely critical to producing consistent, high-quality products. One of the key set of protocols within equipment validation is Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
This quick-guide offers a clear and simple explanation of what these concepts are, why they’re important, what makes them successful, and a model for connecting with professionals who can plan and execute these types of projects.Continue Reading
Since first calling attention to the recent increase in inspection and enforcement activity involving over-the-counter (OTC) drug and health product manufacturers in our April 10 post, multiple additional warning letters and an import alert have only further underscored the need for establishing and maintaining a robust quality system consistent with CGMP regulations.
Read on for a summary of the most recent quality and compliance issues cited by regulators at OTC manufacturing facilities.Continue Reading