16 BioPharm International eBook March 2018 www.biopharminternational.com
Outsourcing Resources Quality Agreements
Good Quality Agreements Support
Compliance with CGMP
Drug manufacturers can improve use of quality agreements
in contract manufacturing.
PAULA KATZ, TAMARA ELY, LINDA JOY, AND JESSICA RITSICK
F
DA finalized its guidance on contract manu-
facturing, 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 ulti-
mately ensure compliance with current good manu-
facturing practice (CGMP).
In the months since FDA finalized this guidance,
how has industry responded? Are manufacturers that
establish contracts for specific manufacturing activi-
ties using quality agreements effectively? The answer
is mixed; yes, many are, but there is room for improve-
ment. 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 pro-
vides some examples of issues related to quality agree-
ments that FDA has called out in warning letters since
the guidance was finalized.
PAULA KATZ is director, Guidance and Policy Staff in the Office of
Manufacturing Quality, Office of Compliance;
TAMARA ELY is senior policy
advisor in the Office of Manufacturing Quality;
LINDA JOY is writer/editor
in the Office of Manufacturing Quality, Office of Compliance; and
JESSICA
RITSICK is regulatory counsel in the Office of Manufacturing Quality, Office of
Compliance; all at the Center for Drug Evaluation and Research, FDA.
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