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Linda Joy is writer/editor in the Office of Manufacturing Quality, Office of Compliance; at the Center for Drug Evaluation and Research, FDA.
Jessica Ritsick is regulatory counsel in the Office of Manufacturing Quality, Office of Compliance; at the Center for DrugEvaluation and Research, FDA.
Paula Katz is director, Guidance and Policy Staff in the Office of Manufacturing Quality, Office of Compliance; at the Center for DrugEvaluation and Research, FDA.
Tamara Ely is senior policy advisor in the Office of Manufacturing Quality; at the Center for Drug Evaluation and Research, FDA.
Drug manufacturers can improve use of quality agreements in contract manufacturing.
FDA finalized its guidance on contract manufacturing, Contract Manufacturing Arrangements for Drugs: Quality Agreements, in November 2016 (1). This document explains how parties that engaged in contract manufacturing can use quality agreements to delineate their roles and ultimately ensure compliance with current good manufacturing practice (CGMP).
In the months since FDA finalized this guidance, how has industry responded? Are manufacturers that establish contracts for specific manufacturing activities using quality agreements effectively? The answer is mixed; yes, many are, but there is room for improvement. In this article, the authors cover the scope and legal underpinnings of the guidance, as well as what FDA investigators may consider regarding a quality agreement during an inspection. The article also provides some examples of issues related to quality agreements that FDA has called out in warning letters since the guidance was finalized.
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Outsourcing Resources 2018
When referring to this article, please cite it as P. Katz et al., "Good Quality Agreements Support Compliance with CGMP,"
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