Nicola Rapley, Global Marketing Manager for Pharmaceutical and Medical Devices at Videojet Technologies, looks at the importance of effective data management solutions in the pharmaceutical industry
Complex coding requirements driven by serialisation regulations are creating an increased demand for multifaceted data management solutions. As a result, manufacturers are looking for printers equipped to handle vast data management responsibilities.
In India, the Directorate General of Foreign Trade (DGFT) is responsible for serialisation requirements for those companies looking to export pharmaceutical products to foreign markets. In January of this year an amendment to policy was announced with regard to ‘The implementation of track and trace requirements for the export of pharmaceuticals and drug consignments’i. At a primary level, companies were required to incorporate a 2D barcode encoding a unique and universal global product identification code in the form of a Global Trade Item Number (GTIN) – this also included a batch number, expiry date and a unique serial number. This bar code labelling at a primary level has been exempted by DGFT until further notice, but is required to be printed in human readable form on an optional basis.
On a secondary level, one or two dimensional barcodes including GTIN, expiry date and a unique serial number are required, while for outer cases one dimensional barcodes are stated with the same requirements. For parent child relationships – the relationship of the data between all three levels of packaging, with outer cases as parent to secondary and secondary as parent to primary packs – data must be uploaded onto a central portal (DAVA). Non-SSI (or large) manufacturers have been required to maintain records and report data to DAVA across all packaging levels since April 1, 2016, whereas SSI companies are only required to upload data at the outer casing level. After March 31, 2017, SSI companies will be required to perform the same level of data management and reporting as non-SSI.
How printers can help with data management?
Serialisation is impossible without coding and marking, and regulatory compliance is likewise impossible without accurate and effective data management. Printing solutions, such as thermal inkjet (TIJ) and laser coders, are designed to be highly versatile, with advanced communication and data handling capabilities, enabling them to integrate with whichever track and trace technology a manufacturer has adopted.
Asynchronous communications is one such capability. In the past, if there was an issue with a printer the management interface would have to send a message from the line management system to check whether it was functioning correctly – referred to as polling. The printer, in turn, would report back to the system that there was an issue. The latest technology allows the printer to send unsolicited information to the line control system the second there is a printer event. If you are dealing with a large amount of data, this proactive reporting of errors can help to achieve major savings in terms of stopping the line immediately and resolving issues quickly, leading to higher potential throughput and significantly reduced data traffic. It is preferable to polling as the data is received in real time.
Printer memory is also important when looking at serialisation solutions. Some serialisation solutions transfer serial numbers to the printer printed one record at a time, referred to as unbuffered printing. When multiple records are sent at once but printed only once each, a buffer is used to store numbers until they are printed, increasing the demands on the printer. If there is an unexpected stoppage on the line, intelligent coding devices are able to communicate which codes are still available for use, meaning codes can be reclaimed as opposed to wasted. This capability is especially relevant when codes have been purchased for use – as is the case with the Chinese government. The latest TIJ printer from Videojet, for example, has a buffer capacity to store hundreds of codes. An index is also kept of the last printed code, which allows manufacturers to continue from the correct code should the line be stopped for any reason.
In addition, given the global markets pharma manufacturers operate within, printers need to have the ability to operate using an extensive number of characters, including Cyrillic, Arabic and pan-Asian languages. By employing Unicode encoding technology, printers are able to encode over 1m characters, which in turn unlocks access to a wide range of global languages.As serialisation deadlines loom, and in some instances have passed, it is imperative that data is managed in an effective, accurate manner that will allow manufacturers to remain compliant and to continue running lines at optimum speeds. Ensuring your coding and marking systems are up to the job will be an essential element to consider, as serialisation simply cannot work without this vital piece of the puzzle.
Reference:
http://dava.gov.in/files/PublicNotice_05_2016.pdf
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