QRM Process

Wyeth’s Charlie Portwood: Focus on QbD Before ICH Q 8-10

After his keynote speech at the ISPE meeting in Las Vegas this week, Charlie Portwood, president of Technical Operations and Product Supply at Wyeth Pharmaceuticals, shared his views on pharma’s supply chain management and quality.

By Agnes Shanley, Editor in Chief

PhM – What have been the biggest challenges that Wyeth has faced after the Consent Decree and during its cultural transformation?

CP – CEO Bernard Poussot really led the company’s transformation. He realized that many aspects of our operations, not just manufacturing and compliance, would be difficult to change, so he led a significant effort to reduce complexity and get the company out of business areas that were not profitable.

After the consent decree five years ago, Bernard participated fully in all talks with the FDA. We used to meet every Friday at 7:30 a.m., and Bernard never missed a single meeting.

We took a strategic approach, and saw that investing in compliance would be the most important step. We also broke operations down into autonomous units with leaders including Michael Kamarck, senior vice president of Wyeth Biotech, and Peter Bigelow, senior vice president of Wyeth Consumer Healthcare. We gave them the authority to change maneuvers and focus very quickly. This whole organizational effectiveness process included strategy at the top and all the way through the organization.

It was critical to have the right people in the right positions. But our integrated, standardized systems approach also allowed us to get more from our IT. We leveraged that all the way with LIMS and we’re still capturing the value. We put major effort into “Class of ´99” products, especially biotech.

Mike Kamarck worked on Prevnar for three years, and his involvement was an important part of ensuring the future of that product. We worked on 122 different projects to address plant issues, build and improve training, and so far these efforts have paid great dividends.

PhM – I notice that your title includes “Product Supply.” Is supply chain management becoming a more integral part of the drug manufacturing job description?

CP – During Wyeth’s transformation, around 2002, we had a big project in place to improve our supply chain management. But we saw that we were trying to do too much. Consider the temporary shortages of Prevnar at the time. If a plant couldn’t supply enough material, we figured that supply chain improvement wouldn’t help the situation. We focused instead on compliance and operational excellence.

But just this past summer, we launched a major supply-chain transformation. We’ve also had a pilot involving SAP and APO (Advanced Planner and Optimizer) in place for the last year and a half, and have had great success with pilots in Europe, Latin America and the Asia-Pacific region.

The new head of that project comes out of the commercial side, and we expect him to leverage that knowledge broadly.

As far as employee training, operational excellence and Six Sigma are already key elements. We also have a “leaders of the future” program, a three-day interactive exercise with top leadership.

PhM – In the press. it was recently reported that AstraZeneca plans to outsource all its manufacturing in 10 years. Is that the way you see the industry moving?

CP – Wyeth may be one of the most heavily leveraged pharma companies in this area. In small molecules, we contract out nearly all of our API manufacturing, which is capital-intensive and complex, especially after a generic version of a drug appears. A few years ago, the figure was 65%, most of it from small-molecule APIs. Today, the outsourcing figure is lower, as biotech grows. We’re doing most of our biotech work in-house.

But about three years ago, we launched a formal supplier network organization for our consumer, biotech and small molecule divisions, in which we treat affiliates like plants and drive the same strategies that we use within our own manufacturing units through our external supply network groups.

PhM – What drawbacks remain to changing pharmaceutical industry quality systems and developing truly global compliance standards? Are you seeing progress toward true harmonization?

CP – The only barrier to new quality systems is us. I sometimes worry that the industry is biting off too much with ICH 8, 9 and 10, and trying to go too far too fast. In contrast, I love Quality by Design, and I’d like to see the industry focus on this principle, since it changes the traditional way of thinking and allows you to incorporate a risk-based approach.

Wyeth and other major pharma companies participated in the FDA pilot project. QbD represents a true paradigm shift for pharma.

As far as global harmonization is concerned, regulators in the U.S. and Europe are trying to work much more closely together. They recognize that the more things they can do alike, the better.

In the meantime, at Wyeth, we are driving as many development projects as possible, using Quality by Design. We hope to do other pilot programs in QbD, including biotech.

Editor’s Note: To read about Portwood’s presentation at ISPE, visit http://www.pharmamanufacturing.com/onpharma/?p=1371.

 

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