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Case study: Contract packager builds its own serialization solution

CMO/CPOs faced with a global client base, obligations to meet multiple and varied country regulations, and the insane complexity of integrating with multiple customers would do well to heed the story of Almac Pharma Services.

Almac is a global pharmaceutical contract manufacturing and packaging service provider to more than 600 pharmaceutical and biotech companies worldwide. In addition to packaging services, the firm provides R&D, biomarker discovery and development, and active pharmaceutical ingredient (API) manufacture and formulation development capabilities.

The company, with 3,000 employees, is based in Craigavon, Northern Ireland, and has U.K. facilities in Elvingston and Manchester. In the U.S., it has facilities in Durham, NC; San Francisco; and two sites in Pennsylvania—Souderton, site of a recently opened, $120 million, 240,000-sq-ft North American headquarters facility; and Audubon, the company’s U.S. commercial pharmaceutical co-packing flagship operation.

Build versus buy
At the time of Almac’s initial requirements gathering in late 2009, there were many unknowns in the regulatory area, not least in the U.S. and E.U. Not only did it need a system that would address the majority of known serialization requirements, but it also needed one sufficiently flexible to permit any addition of updates to meet future global legislative e-pedigree and serialization requirements, in effect future-proofing of the system as much as possible. At that time, there was simply no configurable system that offered this flexibility.

Since Almac had the in-house engineering and information technology expertise, it decided to build its own solution. Being self-supportive was an important factor, since the company did not want to be in a position to rely on a vendor for updates and support, nor did it want to rely on a vendor’s interpretation of global regulations.

Designing the system internally also allowed for a phased approach and a validation effort consistent with business and client requirements. And because it was designed in-house, it could be completely customized around current internal processes, thus reducing the impact of integrating the new equipment and processes that serialization would require.

A final benefit of a custom-built system is that Almac would possess the expertise in-house to customize the system to any customer requirements.

(For example, some customers are serializing not in response to regulatory or country requirements, but for internal stock control reasons. Such customers may have differing information they would require to incorporate within the 2D code, a different serialization number structure, etc.)

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