Strengthening the Chain: Addressing Pedigree Challenges Across Outsourced Operations - Manufacturers should begin preparations now to be ready for the coming requirements. - BioPharm International


Strengthening the Chain: Addressing Pedigree Challenges Across Outsourced Operations
Manufacturers should begin preparations now to be ready for the coming requirements.

BioPharm International
Volume 21, Issue 10


Because manufacturers are ultimately responsible for the accuracy and timeliness of pedigrees and serialization, they should also take steps to ensure data integrity, system interoperability, and proper and sufficient testing of both internal and external systems. This means that despite the current regulatory uncertainty, manufacturers should move forward cautiously with planning for serialization and pedigree. They should develop a compliance strategy for each product that incorporates an evaluation of current packaging, warehousing, and distribution processes, identifies any gaps, and outlines pr+ocess changes required to be compliant. They should also begin to coordinate with their outsourced partners to address the challenges outlined above, and move forward cautiously with selected pilots. The strategy and plans are inexpensive preparations to ensure that once the regulatory fog clears, the timing of piloting and implementations can be aligned with requirements, and also coordinated with upstream and downstream trading partners to ensure that adequate testing can be performed.

Although the current industry emphasis is on compliance with state and federal laws, (pharmaceutical and biotechnology) manufacturers should also bear in mind that pedigree laws are one facet of the broader industry objective to secure product and supply-chain integrity, and, ultimately, patient safety. Threats to safety and integrity of drug supply can arise from a host of areas, including deliberate counterfeiting and diversion, parallel imports, and product tampering, which are all outside of the scope of serialization and pedigree. The recent highly publicized heparin scandal is an example where product integrity and patient safety was compromised because of poor quality standards, testing methods, and product adulteration at an outsourced manufacturing site. However, pedigree laws are focused on securing the supply chain after a product is manufactured. Therefore, the heparin contaminaton would not have been prevented, or even identified, through compliant pedigrees. Pedigree compliance, and serialization in particular, should be viewed as part of a more comprehensive product security strategy that includes other anticounterfeiting, track-and-trace, and product security measures.


Threats to the integrity of the drug supply are likely to intensify in the coming years. Although enforcement of the California pedigree law has been delayed until January 1, 2011, the complexity of implementing mass serialization across outsourced operations will lead many companies to continue working toward compliance now. Most manufacturers expect that a mass serialization solution will take between 18 and 24 months to design and implement. Furthermore, inventory levels at 3PLs and wholesalers are likely to push companies to become fully compliant with pedigree laws well before the published deadline. This puts added pressure on manufacturers with outsourced partners. Failure to take action could place companies at risk of non-compliance in time, potentially leading to penalties. Consequently, it is important that manufacturers with outsourced operations continue to prepare and engage all outsourced partners to proactively design and implement mass serialization solutions.

Todd Applebaum is the vice president of strategy and operations, Scott Dicks is the practice manager of brand integrity, and Frank Gaibor is a senior consultant, all at Maxiom Group, Waltham, MA, 781.250.4900,

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