A safe, secure and effective supply chain needs to be transparent and have all the supply chain partners to work in tandem inorder to track, trace and verify authenticity of products. As Serialization aids in meeting these objectives through assigned unique identifiers and by finding faulty products within the supply chain, aggregation builds on the parent-child relationships from pallet to case to individual pack-level products.
So what should CMOs know about serialization and aggregation?
Mainly these two points:
Advance planning for Supply Chains
Have a lasting Aggregation Strategy
Aggregation has become a focus for the FDA in the US especially because of the Drug Supply Chain Security Act (DSCSA) section 203 mandate which states, “the transaction information required under this section shall include the product identifier at the package level for each package included in the transaction”. A CMO partnership can help with challenges that can arise because of this and they may be applied to traceability, serialization and aggregation. This will help in smooth, continuous operations and sooner releases to the market. There will need to be considerations to comply with global regulations and adhere to GS1 standards, in implementing the processes for the Prescription Drug Security Alliance regulations.
Advance planning for Supply Chains
Global requirements are not just complex but are continuously changing and vary from country to country; thereby making them harder to comply with. For example, countries not following Gs1 standards (China) or Product Codes being used in the US and EU which illustrate how compliance requirements vary from country to country especially in formats and data elements. There needs to be constant keeping track of all the changes for global requirements to avoid unpreparedness when the new requirements do come into effect.
As data reporting is variable, it may be shared with government agencies and supply chain partners once generated upon product imports. This too varies from country to country for example, The EU data requirements depend on the nature of a product and the logistics (with the exception of products that come under article 23). In the US, the data that is verifiable is at product distribution level. With products being destined for global distribution, it’s difficult to be compliant as the data is exchanged throughout the supply chain.
Have a lasting Aggregation Strategy
In order for uninterrupted tracking and product authentication throughout a Company’s supply chain, there must be a robust aggregation process in place. It will allow companies to have control over product changes and the data in different stages of movements. This allows operational practices to have effective inspections, checkpoints and activities (re-packing, re-palletization, etc) till it reaches patients.
CMOs should be able to meet the demands and requirements of a diverse market and adjust to accommodate operational requirements to ensure data integrity throughout the entire supply chain. Packaging lines should be serialization ready and must have aggregation capabilities, with many sites on track to be ready ahead of the DSCSA deadline of 2023. They should be ready to implement plans for timely deliveries on global aggregation requirements that will strengthen pipelines and bring essential drugs to patients at the earliest.
CosmoTrace provides a reliable team of experts who can help with serialization and aggregation.
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