Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility – focusing more heavily on identifying and monitoring critical process steps than on reviewing batch records.

The different tact that Hospira is taking in its compliance remediation efforts reflects the challenge of keeping its operations going at the Rocky Mount plant while overhauling its quality management program.

The extent of the FDA concerns at the plant, expressed in lengthy 483s over the past few years and underscored in a warning letter in April, 2010 (IPQ “The News in Depth” August 26, 2010), would typically have resulted in a plant closing, potentially under a consent decree, until the remediation could be assured by the agency.

However, the role Hospira plays in supplying medically necessary injectables and the threat to the healthcare system if that supply were disrupted has lead the agency to work with the company in achieving the overhaul while production continues.

At FDLI’s mid-December “Enforcement, Litigation & Compliance” conference in Washington, D.C., Quintiles Consulting Senior Director Michael Levitt and Hospira Global Quality Senior VP Zena Kaufman provided a revealing update on Hospira’s efforts to walk this tightrope and advance its quality oversight program at the facility with the help of QbD concepts (see box below).

Levitt has been directing Quintile’s engagement with Hospira in its remediation efforts. He reviewed the compliance context in which the efforts are taking place and the emphasis being placed on heightened monitoring of critical process steps rather than of batch documentation.

Kaufman explained further the “roadmap” the company is following in its efforts to take the Rocky Mount plant from remediation to quality improvement, and the metrics it is using to measure success.

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