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GAMP4: From Pharma to Food?

Many believe that the strict controls associated with the Good Automated Manufacturing Practice Guide for Validation of Automated Systems will likely be applied to the food industry.

Will GAMP4 procedures make the leap from the pharmaceutical industry to food? Probably, was the consensus of many at the Rockwell Automation Fair held in Milwaukee, WI, in mid-November 2003. (GAMP4 stands for Good Automated Manufacturing Practice Guide for Validation of Automated Systems.)

With the Bioterrorism Act of 2002 going into effect next month, the strict controls associated with GAMP4 provide a framework for locking down variables in a packaging process while it's running, according to Tropicana's Glenn Johnson. "People keep fiddling with PLC programs," which can introduce variability in the packaging process, he said. "We need to have a record of every keystroke" to control any changes to PLC programming.

Tropicana is looking at validation of incoming packaging materials and of its processing and packaging operations for cradle-to-grave product traceability.

As part of this trend, Johnson also foresees an increase in the food industry of inspection systems required to verify fill weight, fill level, presence of the proper label, proper cap application, and more.

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