The cost of validation

Conversations we’ve had lately with packaged goods manufacturers suggest that some of them are beginning to soften their insistence on a preferred packaging machinery controls architecture that they have established for themselves. Why?

Because when a builder of packaging equipment settles on a controls package, he can build machinery faster and deliver it at a more attractive price. If he has to replace the controls components with what his customer wants, he can’t build or deliver or maintain equipment as efficiently.

Drug manufacturers, however, are typically not among the packaged goods manufacturers who are taking this “enlightened” view. Why? Because the controls architecture that the drug company has settled on as its standard has already been validated by FDA. If a different controls package must be validated, it causes such a delay in getting the machine delivered and getting product out the door, it makes more sense to have the packaging machinery builder spend time and money removing the controls architecture that he happens to prefer and replacing it with the one his customer prefers. Yes, the packaging machine will cost more and take longer to deliver. But that upcharge is easily offset if, at the end of the day, product can go to market sooner because FDA validation doesn’t enter the picture.

Still, there’s something wrong with this picture. One packaging machinery builder put it this way: “Sometimes we wind up creating a Frankenstein by caving in to the customer’s request instead of sticking to our guns where controls are concerned.”

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