JUL-AUG 2017

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INTECH JULY/AUGUST 2017 17 PROCESS AUTOMATION dangerous drug, through acquisition and sale by one or more wholesalers, manufacturers, or phar - macies, until the final sale to a pharmacy or indi- vidual furnishing, administering, or dispensing the drug. Serialization, however, is not yet harmonized worldwide due to varying standards. This presents a challenge for manufacturers. In the U.S., for ex - ample, the Drug Quality and Security Act (DQSA) was enacted by Congress in 2013, but the Food and Drug Administration continues to delay enforce - ment, with the latest deadline moved to 27 Novem- ber 2018 and implementation of all requirements currently targeted for 2023. GS1 Standards, which are already used in 25 dif- ferent global industry sectors, appear to offer the best opportunity to achieve a single global stan- dard. GS1 is an international not-for-profit asso- ciation with members in more than 100 countries. GS1 is dedicated to the design and implementa- tion of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world. These standards define how products, services, and businesses are identified for electronic commerce by using alpha numeric characters formatted in a specific fashion. These specifically formatted identifiers are com- monly represented on products as two-dimen- sional data matrix bar codes or radio frequency identification tags used by automatic identification systems to avoid data transfer errors. All the infor- mation collected in production and on packaging lines needs to be stored in the enterprise business system. In the future interoperable world of distri- bution, this information can be sent to those phar- macies where product is delivered to the consumer. Standardized global approach The program has global sponsors throughout the organization, including manufacturing, supply chain, information system, and quality. There are many advantages to a standardized global approach: l Many resources from multiple sites are avail- able to tackle a common objective. l Knowledge and testing is centralized. l Tests can be executed once and leveraged across many lines (370). l Capital costs are reduced, and the organization has better cost control (through buying power). l Vendor documentation is reduced. l Continuous improvement lessons from one site can be implemented at the next. Extra time is required for global alignment and coordination. Serialization best practices At item level l At print and inspect, print on the package flap. Check the data matrix (two-dimensional bar code) grade equivalent and serial number uniqueness (duplicate check). l If checking length, weight, and orientation, do the print check afterward to minimize manual decommissioning requirements and reduce the effect on overall equipment effectiveness (OEE) because of rejecting coded product. l Quality control sampling: Sampling status, either manual or auto, this status must be locked. l Shared packs: One unique identification/data matrix (DM) (national codes inside). If this is not possible, reduce or avoid shared packs. Printer (to achieve a grading result of A) l May require ink-to-paper substrate optimization. l Print carton at the most stable location or idea surface. l Optimum resolution identified as 240 dpi. l Human readable text is 2 mm, with OCR-A or B font (print font recognizable by com- puters and humans). l Have cartridge clean- i n g p ro c e d u re i n place. FAST FORWARD l Learn from Sanofi's experience in applying a single, harmonized approach to serialization across all aspects of its program. l The program involves 58 sites and more than 350 packaging and distribution lines. l Lessons learned include the challenges of global harmonization, optimizing printing and packaging, tamper evidence, and OEE. The key driver of the serialization program is the traceability regulation (country by country). Turkey 2010 • Jan 2010: DM serialization • Jan 2012: Aggregation Regulation highlights Target dates China 2011–2015 Argentina 2011–2014 Serialization and aggregation for special products Serialization and aggregation Special products in 2011 and all medicines in 2015 India 2016 Serialization and aggregation of all exported medicines + comply with existing countries' regulations South Korea 2015 Serialization and aggregation (100% reconciliation) Progressive plan Jan. 2015: 30% of products Dec. 2015: 100% of products Saudi Arabia March 2017 U.S. Nov. 2017 Serialization (+100% reconciliation?) Serialization of packs and cases (+ aggregation Nov. 2023 or Nov. 2019) Egypt 2018 Serialization (Jun. 2018) TBC and aggregation (Jun. 2019) Russia 2018 Serialization and aggregation pilot in 2017 Critical drugs in Nov. 2018, vital drugs in 2019, and all medicines in 2020 TBC Europe Feb. 2019 Taiwan (TBC) Serialization of high-risk products for all countries (except BE, IT, and GR, Feb. 2025 at the latest) Serialization (Jan. 2019) Jordan 2020 Serialization 2020 (+100% reconciliation?) Brazil 2019+ (TBC) Serialization and aggregation (DM) printed directly on the pack (delayed) Program implementation Turkey, Argentina Europe, U.S. lines Brazil, Saudi Arabia Manufacturing A Manufacturing B Manufacturing C Manufacturing D Manufacturing E Manufacturing F DC repackaging DC packing stations Division Done 2014 2015 2016 2017 26 7 36 63 58 190 5 7 26 27 65 0 19 12 29 13 73 1 2 8 17 2 30 0 1 4 5 1 0 1 2 3 1 1 5 23 22 9 2 56 Total to be equipped Regulatory timeline # Lines South Korea China 36 37 88 136 73 370

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