In Pharmaceutical Manufacturing’s April issue cover story, Agnes Shanley takes “The Pulse of Pharmaceutical Manufacturing.” The past decade has seen dramatic shifts in the way we talk and think about drug manufacturing, but, she asks, have practices really changed in the time since FDA’s PAT team was formed and then-Commissioner McClellan wondered why pharma manufacturing was “behind that of potato chip and soap making”?

 Read more...

An upcoming event that may have flown under your radar is “Operational Excellence: A Lifecycle Approach to Assuring Drug Quality,” to be held April 5 – 6 at the Hyatt Regency in Bethesda. It’s a great, relevant topic, of course. But what distinguishes this conference–sponsored by NIPTE–is the impressive lineup of speakers, from FDA, industry, academia, and consulting and vendor companies.

 Read more...

In this just-posted video, courtesy of the U.K.’s Cranfield University School of Management, Catalent Pharma Solutions’ VP of Operations Mark Dean-Netscher outlines his firm’s approach to operational excellence and continuous improvement. The aim is to sustain a culture of manufacturing improvement throughout the organization. Catalent, Dean-Netscher explains, takes a very mechanistic, standard work approach that is easy and predictable for shop-floor workers to understand, and reflects a clear, systematic vision of management. It’s a matter of “making the routine routine,” he says.

 Read more...

By Ali Afnan, Principal, Step Change Pharma

For the past decade, industry and FDA initiatives have focused on changing the drug industry’s culture, to make drug development and manufacturing more efficient while improving product quality. How successful these efforts have been depends on whom you ask. Regulatory agencies, particularly FDA, see the glass as half full. After all, they say, the term “design space” has become part of the pharma lexicon, and leading drug companies have submitted multiple Quality by Design (QbD) applications, many of which have been approved.

 Read more...

By Agnes Shanley, Editor in Chief

Ulf Schrader, a partner in McKinsey’s German office and leader of the company’s Pharma/Ops joint venture, recently discussed Toyota’s recent crisis, lessons it may offer the pharmaceutical industry and pharma’s implementation of the Toyota Production System.

 Read more...

At FDA’s May 11-12 “Partnering with Industry” conference in Bethesda, Maryland, Emerson Process Management COO Melissa Herkt discussed the need—and opportunities—for change and inspirational leadership within pharma in order to drive PAT, QbD, and modern manufacturing excellence. (Video below.)

 Read more...