Serialization track and trace deadlines


In over 40 countries, regulatory mandates to secure the pharma supply chain are already in place or in development.

Despite the urgency, many medicine manufacturers are known to be behind schedule with serialization projects. In our 2016 research a number of participants admitted to not even thinking about serialization at all as of yet.

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Download this printable map to assist with your worldwide track and trace compliance strategies.

Supply chain
 expert Tracelink predicts that as many as 400 contract manufacturing organizations (CMOs) will not be ready for the approaching US and EU serialization compliance deadlines. Tracelink estimates this equates to 50 per cent of the US’s and EU’s CMOs. This would leave many pharma firms without adequate support for serialization deadlines and, therefore, could spark a major shift in the CMO marketplace.

The late adopters are going to be critically reliant on excellence in project execution to get their programmes in place and delivered on time. A high level of optimism was implied in last year’s results in regards to time left to complete serialization projects. With deadlines looming, instead of being complacent the industry should utilize the time left to avoid any costly mistakes.

The more prepared manufacturers are assessing the returns available from the legal requirements. More than 70 per cent of manufacturers, in a recent industry study commissioned by KPMG, appreciated that serialization requirements will have a positive impact on their business processes.

Ahead of the 2018 Serialization and Traceability event, We have created this map to provide an overview of various nations’ progress in their serialization journey.

Global pharmaceutical companies lose an estimated $75 billion annually to prescription drug counterfeits — not including costs of diminished brand value.

Impending government regulations will require comprehensive serialization elements not just in your manufacturing facilities, but also across the supply chain.

The challenges stand tall in serialization projects. These campaigns involve engineering systems at line, distribution, operation levels, as well as enterprise IT systems at site and global levels. The late adopters are going to be critically reliant on excellence in project execution from a variety of departments to put programmes in place and delivered on time.

Any implementation programme being initiated now faces a daunting amount of complex capability that must be delivered in a very short time with little or no opportunity to practice before deadlines hit.

Read this whitepaper for insight on the key considerations with serialization project’s integration to ensure you avoid making costly mistakes.

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