Pfizer Manufacturing Deutschland GmbH wins Facility of the Year Award

Streamlining C&Q

The philosophy of improving and streamlining NEWCON’s design also was applied to NEWCON’s Commissioning and Qualification (C&Q) approach.

“If we used the conventional approach of ‘the more the better,’ we simply would have missed the timeline.

We had to come up with something different,” said Weyhers. “We have a saying within Pfizer Global Manufacturing: Shamelessly steal good ideas. We simply made use ofthe ISPE GAMP® 4 Guide.”

“Based on risk assessment, we categorized our systems into Direct, Impact, and Non-Impact systems and this really helped to funnel down the overall validation approach and unburden the organization,” said Weyhers. ”We managed to shift the major chunk of the workload toward the vendors.”

“At the end of the day, it’s the product that counts,” said Bernhard. “The equipment and facility serve one purpose, and that’s to produce a good, safe, quality product for the patient. We focused on what was important, and l’m happy that this logical approach is becoming more and more prevalent in the industry.”

Crazy Can Lead to Pioneering

The vision for NEWCON started a few years ago with a team of experts asking crazy questions and answering with ‘why not?’ said Bernhard.

Today NEWCON provides pioneering ideas for the future, not only in containment production, but for the entire field of pharmaceutical manufacturing, said Bernhard.

“It is certainly plausible that the degree of automation that Pfizer Illertissen has achieved in NEWCON will be standard for the pharmaceutical sector in one or two decades,” said Bernhard. “And it is just as likely that the fully-automated containment technology will then be used not only for highly potent substances, but also in other areas of pharmaceutical manufacturing. For example, perhaps the single-room concept can be applied to a packaging line.”

“These days, with cost pressures, decreasing direct labor costs, and market challenges, automation should be considered in facility design in order to be competitive in this industry.”

For additional information about the Awards program, and access to the online submission form, visit www.facilityoftheyear.org.

Download the PDF version of the article.

Pages: 1 2 3 4