Serialisation.

Our Serialisation service comes with a wealth of experience and competency. With track and trace, we combat counterfeiting, keeping patients and your business safe.

Dedicated in-house serialisation specialists

We directly employ dedicated serialisation specialists, keeping these skills in-house creates a robust process, immediately addressing issues that would otherwise slow a project down adding cost. Our specialists maintain knowledge of global serialisation requirements and adhere not only to GMP and regulatory standards but our own strict standard of excellence.

Global directives covered and standards

We have been serialising and aggregating pharmaceutical products for global markets since 2014. We are proud to have become a leading partner to Marketing Authorisation holders for their global serialisation and track & trace requirements, including EU Falsified Medicines Directive (2011/62/EU) and U.S. Drug Supply Chain Security Act.

Anti-Tamper Device (ATD) application

Our serialisation lines code, scan and verify on-pack data, are equipped with tamper evident sealing machines to apply the Anti-Tamper Device (ATD) to each pack, and include aggregation stations for full traceability to shipper and pallet level – all services include validation.

Reworking

We can rework previously serialised product and, if required, provide a simple late stage serialisation only service for pre-packed stock. Our approach is flexible and can be tailored to act as an extension of our clients’ – or their Contract Manufacturing Organisations’ – own operations.

Data management

We have vast experience in connecting to other third-party software vendors. Our dedicated IT team make the company and product-level onboarding processes efficient and uncomplicated for the Marketing Authorisation Holder.

Full aggregation

We have ample serialisation and aggregation line capacity and are continually investing in additional hardware and software to ensure that the products we pack comply with current and emerging legislation in global markets.

Full aggregation enables full visibility and traceability of a product throughout its entire life cycle.

The data aggregation from your production batch consists of a report containing a parent-child hierarchy, which ranges from the carton up to the pallet level.

Central Pharma will manage your data throughout the process. We also have the ability to store and report your serial numbers to your required destination.

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Drop us a message to discover our full range of services tailored to your business and find out how Central Pharma can be your intelligent pharmaceutical partner.

 

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