Contract Organization Maintains Flexibility While Meeting EU FMD Requirements

With a range of product and packaging formats, U.K.-based contract packager Wasdell Packaging Ltd., part of the Wasdell Group, required a set of serialization systems to meet requirements.Training and contingency plans are also top priorities.

With such varying packaging capabilities, the CMO required flexible equipment, and selected Optel Group as its supplier.
With such varying packaging capabilities, the CMO required flexible equipment, and selected Optel Group as its supplier.

February 2019 marked the compliance deadline with the EU Falsified Medicines Directive, while companies remain in varying states of readiness. Contrasted with U.S. DSCSA requirements, the EU regulations pose unique challenges.

“The main difference from U.S. to Europe is the sheer number of SKUs, markets and products,” says Daniel Tedham, Managing Director of Wasdell Manufacturing, a division of the Wasdell Group. “The U.S. has one market and database. Compare this to Europe where there are many countries with many different languages–which equate to different SKUs as well as different healthcare authorities–and you can see the obvious added complexity.”

In Europe, while there will be one hub and database, some countries will still require different formatting and print layout for serialization. Batch sizes required are different as well. “Put simply, it is not going to be consistent across the board. There are also different reimbursement requirements in countries such as France and Italy and different artworks with individual country requirements that need to be met. This is where flexibility and reactivity are required.”

U.K.-based outsource partner to the life science sector, The Wasdell Group operates three facilities, with a fourth to open in Ireland in 2019. In total, the group runs 29 packaging suites across all three sites: 16 in Swindon, nine in Burnley and four in Newcastle.“Across the group we have cleanrooms operating to Grade D and Grade C, with two having the capability for Grade B,” says Tedham.“Packaging largely takes place in a Grade D environment. On several of the lines we can also control humidity and have two lines with high containment capabilities.”

The company works with a range of packaging formats:

  • Blisters (thermoform and cold-form)
  • Container filling of solid dose, powders, liquids
  • Sachets
  • All types of secondary packing i.e. cartoning and rework, serialization

Volumes range from small orders of a few hundred units all the way to batches of 300,000. “As a CMO/CPO we have to offer flexibility. If the product is relatively standard and high volume, clients will often look to do it in-house, so we rarely deal with orders of vast quantities,” he says. The company typically serves customers whose products are complex, or the volumes do not warrant having internal operations, but require fast turnaround.

Flexibility

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