Twice a month editors here at Pharmaceutical & Medical Packaging

When FDA says something about packaging, pharmaceutical and medical device packaging engineers pay attention. This is of necessity, because use of improper packaging materials or procedures can hold up a new product launch, lead to a recall, or prompt any number of other negative consequences. As a result, packaging design, development, and execution begins with a review of FDA regulations and guidances and proceeds from there.

But it is easy to forget that FDA’s provisions are merely a series of requirements and suggestions that make up only part of the recipe for packaging a product. The rest is up to you, based on your knowledge of your product.

From time to time, industry wants more mandates from FDA regarding a particular regulation or guidance. If FDA were to give a precise indication of how it wants products to be packaged, that would make the drug or device firm’s job easier, wouldn’t it?

But in most cases, we’re not going to see that. FDA, in its embrace of “risk management” and “risk assessment” principles, has acknowledged that it has limited resources and cannot micromanage every single aspect of production. It wants to focus on those products, firms, and processes that pose the greatest risk to public health. In many cases, the minutiae of the packaging operation will not fall into that category. FDA’s packaging regulations and guidelines are aimed at achieving a certain result—protecting public health and ensuring public safety. How you get there is usually less important than demonstrating that you have in fact gotten there.

That means there is much room for creativity, so long as you can demonstrate that you are achieving what FDA wants you to achieve.

On this note, the Institute of Packaging Professionals’ (IoPP; Naperville, IL) annual Eastern Equipment Committee Seminar, held last month in Secaucus, NJ, produced an inspiring tale of two firms that worked together to come up with a validation solution that fit specific needs.

Randy Leinhauser, senior equipment engineer for Wyeth (King of Prussia, PA), and Glenn Barbrey, validation manager for the design group of Barry-Wehmiller (Duncan, SC), explained how they implemented a new validation plan for two liquid filling lines in Wyeth’s Richmond, VA, plant.

“We hired an integrator to do a full line integration including validation,” Leinhauser said. “The goal was to decrease downtime and changeover, while keeping validation in mind throughout the entire process.”

The goal was possible, Barbrey said, because of a new Wyeth validation plan that incorporated validation considerations at the earliest levels, including in user requirement specifications (URS) and functional requirement specifications (FRS). The bottom line, he said, was that by the time it came for the actual installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ), the tasks were relatively simple. They essentially became a check against what was written in the URS and FRS and against what was performed in the factory acceptance test (FAT) and site acceptance test (SAT).

Even though the new system was developed “because the requirements for validation have increased and the resources in my group have not increased,” Leinhauser said, there was no edict from FDA telling Wyeth to perform validation in this way. Instead, the firm designed a plan that met its own needs and resources, and Barry-Wehmiller helped implement it.

Perhaps inspiring is an overstatement—after all, it is validation we’re talking about—but this project is exactly the kind of creative but thorough solution packaging personnel need to come up with in today’s regulatory climate.