MES upgrade tactic: Slay the tweak dragon

Process data are becoming as important as the product itself in drug manufacturing, says the lead engineer on a multi-site implementation of a manufacturing execution system--no process documentation, no product release. So Hoffmann-La Roche is automating across eight sites using the Rockwell Automation MES Core.

Batch data-collection methods pale in comparison to those of an MES, reflecting the current regulatory expectation for mastery of not just process but also process measurement. There's a corporate mandate, too, for greater global operational consistency. The means for serving both masters are centralized best practices and error reduction--all for the end of "significant cost savings," says Robert Fretz in a trade magazine interview.

Fretz, who heads up the MES program as part of Roche's Pharma Global Engineering group, says the centralized approach lets him collect experiences and best practices from all sites into one system, for the benefit of all. It also aligns business processes to uniform compliance and efficiency standards.

One of his key implementation tactics is to keep customization to a minimum. "Although we are challenged to reach less than 10% customizations by the different type of site operations (solids, parenterals, packaging), having too many customizations will lead to being stuck with an older version [of the MES] as costs for upgrades are getting prohibitively high," says Fretz.

- read the interview

Suggested Articles

Fujifilm Diosynth Biotechnologies last year committed 10 billion yen toward its manufacturing operations. It has now kicked off one of those projects.

Popular logic says you never switch horses, or CDMOs, in the middle of the stream, but Acacia Pharma had to do that to win an FDA approval.

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.