Audits, Supply Chain Security and Globalization Covered by Rx-360 at Informex

The Rx-360 Panel at Informex in Anaheim - from top left to bottom right: David McCarthy, Pfizer; Scott Watson, AMPAC; Kim Cauchy, Mylan: Tony Wiederhold, Eli Lilly; Tom Beil, SAFC; William Reiss, AMGEN

SAFC Live had the pleasure of being onsite at Informex in Anaheim, CA yesterday, as members from global quality consortium Rx-360 talked about what keeps them up at night. The roundtable session titled “Attention Suppliers! — This is What Keeps Me Up at Night – How Rx-360 Helps (Me Sleep Better)” provided attendees with a wealth of information about what volunteers with Rx-360 are doing to change the approach to quality in the industry. It also offered a chance for attendees to provide their input about what they are personally seeing on a day-to-day basis and how this affects the future of the pharma industry.

Not surprisingly, a hot topic of discussion was how to maximize the value of audits. There is no question that audits provide exceptional value to both the supplier and the manufacturer, but at what point do they impede efficiency? SAFC’s Vice President of Quality and Regulatory Affairs, Tom Beil, offered his insight by saying that it is important to leverage redundancy in audit so that both sides can focus on keeping development moving. Sharing information within the industry is one way to move towards more strategic relationships that have clear quality expectations addressed ahead of time. This led to the idea of standardized quality agreements for the industry, which the whole audience seemed to think may be the way of the future.

Supply chain security was also a driver of the session. As Martin Van Trieste, Senior Vice President of Quality at AMGEN added from the audience, globalization brings different considerations with it. Most importantly, suppliers need to be sure that they have inventory so that customers (whether another supplier or a manufacturer) can have access to the products they need. Dave McCarthy, Senior Director of Worldwide Procurement at Pfizer, echoed this sentiment and added that it is also important for suppliers to have accountability for the products they are offering. Suppliers who focus on maintaining inventory and providing transparent and detailed information about where these products have come from and what happened to them along the way will undoubtedly gain a competitive edge.

As the session came to a close, the endnote focused on regulatory developments and the market in China. As moderator Scott Watson, Executive Director of Sales and Marketing at AMPAC commented, the true premise of regulations is to secure the supply chain and make it transparent. All of the panel members agreed that part of this would include working to create stronger relationships with international partners like China and looking to ensure that quality is the driver for the pharmaceutical industry, locally and across the globe.

To learn more about Rx-360, please click here.

To learn more about how SAFC approaches quality from the perspective of Director of Quality Services, Gary Perkins, please click here.

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