Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

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Wednesday, October 3, 2018

Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

Written by: David B. Klug, Ralph D. Lindblad, Douglas G. Muse, Katherine L. Ulman, Phyllis Walsh, Priscilla S. Zawislak

In today’s regulatory environment, and with the importance of delivering quality medicines to patients, regulators continue to place even more responsibility on pharmaceutical companies. Although more companies are outsourcing manufacturing, it remains their job to ensure that raw materials used in their medicines, including excipients, are safe, of high-quality, and sourced from reputable suppliers who adopt appropriate manufacturing practices... (click here to read more)