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Achieving Manufacturing Excellence

Achieving Manufacturing Excellence

Medium: Pharmaceutical Technology 41 (3) 2017
Author: J. Markarian

Moving to the next level of productive, reliable performance in bio/pharmaceutical manufacturing requires a willingness to make changes and create a quality culture.

In any industry, manufacturing or operational excellence can be thought of as efficiency, productivity, and reliability, with minimized downtime and few product failures. But excellence is an ever-moving target. “Manufacturing excellence is not just the best way to do it today, but continually improving to the next level,” suggests Hal Baseman, chief operating officer at ValSource LLC.

In the pharmaceutical industry, manufacturing excellence also encompasses the need to serve patients by providing safe and effective medicines without an interruption in supply. Regulatory quality requirements—current good manufacturing practices (cGMPs) and product testing, for example—are designed to ensure safety and efficacy, but opinions vary as to whether compliance necessarily leads to excellence. “Compliance is important, but it is not where a firm should focus the majority of its resources and efforts. The bio, pharmaceutical, and medical device industries must transform to embrace quality beyond compliance,” advises Martin Van Trieste, chairman of the board at the Parenteral Drug Association (PDA).

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