For pharmaceutical manufacturing companies it has become mandatory to dispose of IT tools that rigorously support the entire management cycle as well as the manufacturing process.
The characteristics of the sector and the high-quality standards to undertake have pushed the pharmaceutical industry to extend as far as possible the traceability of the warehouse flows of the entire production process, from the purchase of raw materials to production, from the quality controls to the distribution.
In order to handle this complicated IT process, the pharmaceutical industry relies on specific companies specialized in the development of TRACK & TRACE software.
According to ANSI-ISA 95 (international standards from the International Society of Automation for developing an automated interface between enterprise and control systems), the following technological levels in the serialization system can be distinguished.
Level 0: the manufacturing lines of the pharmaceutical companies (according to ISA-95 “It defines the actual physical processes”).
Level 1: the line devices for marking, labelling and inspecting such as labellers, inkjet or laser markers, vision system and barcode readers, desktop printer (according to ISA-95 “It defines the activities involved in sensing and manipulating the physical processes”).
Arca is a producer of Level 1 solutions.
Level 2: software for the management and control of the serialization process on every single packaging line (according to ISA-95 “It defines the activities of monitoring and controlling the physical processes”).
It allows to receive the serial numbers, send them to the marker and the inspection camera, inspect and acquire the related data, aggregate in multiple packages or perform “reworking” operations, start and stop each production lot, manage the security of the system (CFR21 part11). Once the process of marking and inspecting the unique code is complete, level 2 communicates the serialization and aggregation data to the higher levels.
Level 3: software for the overall management of every single manufacturing site (according to ISA-95 “It defines the activities of the work flow to produce the desired end-products”).
In level 3, the serial number of every product unit are auto-generated or imported from the outside. It is a centralised platform (software installed in a central server which is connected to all packaging lines) that avoids data redundancy, facilitates back-up, allows the safe management of serialisation data while ensuring operational autonomy to every single line.
Level 4: ERP interface software of the pharmaceutical companies towards the other player of the supply chain and the national authorities (according to ISA-95 “It defines the business-related activities needed to manage a manufacturing organization”).
The international regulations impose on every pharmaceutical company to make serialised data available to MAHs (Manufacturing Authorization Holders), CMOs (Contract Manufacturing Organizations), other supply chain partners (hospitals, drugstores), customers and national authorities.
According to the international standard ANSI-ISA 95, further non-manufacturing business-related levels can be determined, especially when it comes to security.
Level 5: the national (or supranational, like for the EU) data base hubs (according to ISA-95 “There are other non-manufacturing business-related activities that may be in levels 1 through levels 4 or higher levels, but these are not defined in this standard”).