Video: DVE Impact Statement: Saji Thomas (P4)
We appreciate that USP’s quality standards are developed through a collaborative and transparent process that brings together the voices and leadership of patients, practitioners, regulators, academics and industry. These standards help create a strong scientific foundation for quality in health and healthcare. They help generic drug manufacturers ensure that safe, high-quality medicines make their way to consumers.
At Par Pharmaceutical, an Endo International operating company, we use USP standards to establish key quality attributes of products as part of our FDA approval process. USP standards provide critical information to demonstrate the quality, purity and strength of medicines, as well as guidelines and reference standards for testing, so that drugs can be made consistently. In this way, USP standards help us advance our products to market, which increases the availability of lower cost, beneficial medicines for patients.
Are there challenges you face in the course of development or manufacturing that USP has been able to help you solve or expedite?
Par releases generic products to market predominantly by USP monographs. At times we are faced with challenges when we detect new impurities or when the method doesn’t perform as expected. When this happens, we immediately inform the USP liaison and our account manager. We usually get a response either immediately or within 24 hours. The account manager follows up with our issue and makes sure that it’s fully resolved.
Is there anything else you would like us to know about your work with USP?
Par Pharmaceutical submitted over 50 monographs in 2019 alone. Working with the USP liaison and our account manager, Par was able to make sure our products meet USP’s quality public standards