IPQ Monthly Update, April/May 2015

In her keynote presentation at the April 21-22 ISPE quality metrics meeting in Baltimore, Maryland, CDER Director Janet Woodcock addressed the concern industry has expressed around the potential for a quality metrics submission program to create fear and encourage behaviors contrary to the Center’s stated objectives of improving quality management systems and encouraging continuous improvement.

Responding directly to that concern in her presentation, she affirmed the Deming principle that fear-based relationships – both internally within companies, and between them and the agency – are indeed antithetical to quality system advancement and that the principle is fundamental as the agency reshapes its regulatory approach. In turn, while fear is a roadblock on the continuous improvement pathway, measurement is a critical driver, Woodcock said, in explaining the principles underpinning FDA’s “quality revolution.”

In the following story, IPQ takes a deeper dive into the relevancy of Deming’s quality philosophy to pharma manufacturing via the insights provided by a Deming Institute expert at a PDA/FDA workshop on quality systems. Pharma is tapping into only a relatively small part of its power, he said, explaining what the industry needs to do to take hold of the rest.

The IPQ issue shifts to the problems FDA’s compliance office is dealing with abroad, where many of the companies it is inspecting have not progressed down the Deming learning curve, and what the implications are for pharma companies who are making outsourcing and purchasing decisions overseas. Noting the high foreign inspection failure rates, a key compliance official stresses that pharma needs to develop better risk models and intensify its supplier oversight abroad. A CDER OPQ policy maker and a field office director also weigh in on the shifting quality regulatory landscape.

The next story keeps the focus on quality systems and the global supply chain. IPQ looks at the impact of the new risk-oriented ANSI NSF-IPEC 363 excipient GMP standard and how its implementation will help ensure compliance with FDASIA, the FMD, and a newly-completed EU excipient risk assessment guideline. The GMP standard needs to be understood by both excipient makers and users and inform their communications, as the story explains.

While the tools and systems for managing the lifecycles of process equipment and utilities are generally well established, they are less so for the complex web of automation process control systems that stretches across a facility. In the final story, IPQ takes a look at Sanofi’s effort to deploy a coherent strategy to ward off the very real threats to product manufacturing that ensue from not understanding and managing the automation system lifecycles and their interrelationship.

Included in the issue are about three dozen “Updates in Brief” on recent developments in the CMC/GMP global arena with links to the referenced documents and to our related in-depth analysis. Also included are the recalls and warning letters listed by FDA during April and May.

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