Stevanato Group is actively supporting an initiative by the Parenteral Drugs Association (PDA) to understand the industry approach to manufacturing traceability. It is, therefore, encouraging customers to take part in this short, 12-question survey. The final goal is to help the community to learn more about how industry, suppliers, and regulators understand the current state of demand and issues surrounding manufacturing traceability
The link is open until 31 October. The PDA will collect and own the data and will publish the results at the upcoming Parenteral Packaging conference in Basel in February 2020.
Tod Urquhart - Core Team Leader for the serialization project – says that “We are applying serialization to containers not for regulatory reasons but to help pharma manufacturing operations streamline filling, inspection and packing, providing product-by-product traceability.”
The principle is simple: every container is given an identity that delivers unit-level traceability. This traceability means that any problem can be narrowed to a defined time window and so the manufacturer does not need to write off the whole batch or be excessively conservative about which parts of it to target.
“There are significant cost savings for customers”, Urquhart adds. “The value proposition has been validated by discussions with customers., We also know broadly the cost of implementation, and so there is a compelling business case,
The survey has been promoted by Stevanato Group in a common initiative with other players in the primary packaging market. “This technology must be industry-wide to be worthwhile to everybody, and it won’t be unless we can facilitate a multi-vendor strategy to customers.