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Q&A: Reducing controls headaches (sidebar)

Reducing pharmaceutical validation costs

Validating packaging systems, an FDA requirement for pharmaceutical packagers, can add up to 40% to the cost of a packaging systems project, according to Martell.

Plug-and-Pack guidelines can help.

PW: How will standards such as Plug-and-Pack save on your validation costs?

Martell: To answer the question, you first need to understand what’s involved in validation. The process of validating packaging systems is really about documenting in extensive detail what the system is specified to do, including the components in the system, the control systems that run the equipment, and how the system operates. The process of developing this documentation in the absence of standards is really a unique exercise for every piece of equipment. It almost involves reverse-engineering the system to get at the detail, particularly in the control system. The typical level of documentation that comes from the OEM doesn’t provide enough detail to generate the specification documents that are needed for FDA validation. That reverse-engineering process is extremely time-consuming and expensive. It’s extra time tacked onto the project, and it’s a difficult piece to predict, especially if the OEM is one you’ve not worked with in the past.

So I and others in pharmaceutical packaging are seeking ways to make those costs and schedules more predictable, and extend the life of the work we’ve done on the previous projects. Let’s create standards that can be built upon from project to project. It will reduce the need to reverse-engineer and completely customize on every job.

See the story that goes with this sidebar: Q&A: Reducing controls headaches

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