Packaging and serialisation hall consolidated

Until now, secondary packaging for the injectable and oral-solid streams ran on separate benches, each with its own coding and case-packing step. Consolidating both into one hall means a single, qualified serialisation line handles every finished pack, regardless of dosage form. The change removes a parallel set of equipment, harmonises the coding workflow, and gives the Qualified Person a single point at which pack-level data is generated and checked before release.

“Consolidating both streams onto one serialised line gives every Ergopharm pack a single, verifiable identity from batch to pallet.”

Each pack now carries a GS1 DataMatrix (ECC200) encoding the product code, expiry, batch and a unique serial — the Application Identifiers (01) GTIN, (17) expiry, (10) batch/lot and (21) serial. Packs are aggregated to cases and pallets using the SSCC, with the parent–child relationships recorded as EPCIS events. Building this hierarchy on one line, rather than reconciling two, reduces the chance of aggregation errors and keeps each unit traceable up and down the pack–case–pallet chain.

The consolidated hall is built to carry the serialisation and aggregation data that verification systems Ergopharm's export markets rely on, including the unique-identifier checks associated with the EU EMVS and the distribution-security requirements under the US DSCSA. Serialisation and its verification sit within the same pharmaceutical quality system Ergopharm operates under ICH Q10, with change control, deviation handling and CAPA governing the line's qualification and its day-to-day running.

In practical terms, the move buys both capacity and clarity. A single line is simpler to qualify (IQ/OQ/PQ), simpler to monitor, and simpler to audit, while freeing floor space previously taken by duplicated coding stations. For customers and distributors, the result is a consistent serialised pack and a single, coherent audit trail from the Batch Manufacturing Record through to the aggregated pallet leaving the site.