AS OF 09/2014 GENERAL INFORMATION LYNX-CAPA China E-Coding Information Introducing From May 1, 2013, pharmaceuticals on the essential drug list published by China’s Ministry of Health require serialisation. All levels of packaging need to be printed with the China National Drug Code and a serial number. The serial number is a 20 digits number that includes manufacturer code, serial number and check digits and is a GS1 barcode. In order to obtain that number, manufacturers use the China Product Identification and Tracking System (PIATS) to register their drugs. For products too small for the barcode, a solution will be found in cooperation with the Provincial Food and Drug Administration. For imports, a local manufacturer, wholesaler or other office needs to be chosen as a local agent to deal with the CFDA on the importer’s behalf. All manufacturers need to follow good manufacturing practice for quality control and electronic drug monitoring etc. By 2015, an e-Pedigree including product information, batch, serialization data, transaction information needs to be made for all products. (Source: China: CFDA Order of Ministry of Health No. 90) Highlights ▪ ▪ ▪ ▪ Tool-free adjustment on folding box and case sizes Serialisation and aggregation implemented Supports GS1, IFA, CIP 13, ITS, Bollino IPZS, Royal Vignette Belge Integration of all major printer systems and China E-Coding Code Requirements Code Specification Barcode type Code 128C according to ISO/IEC 15417 Barcode density > 8 mils Barcode size X > 0.17 mm per module, recommended X > 0.25mm Maximum is not specified, 0.5 mm suggestion Data type Numerical only Data length 20 digits Barcode height > 8 mm Maximum not specified, 30 mm suggestion Barcode Quality Grade ANSI Grade C or 2 according to ISO/IEC 15416 Data Structure Type Length Allowed numbers Assigned by Mark digit 1 Unknown NDC Product code (NDC) 6 Numerical NDC Serial number 9 Numerical Manufacturer Check digit 4 Numerical Calculated, algorithm unknown 11 modules Stop trigger 13 modules Check digit 11 modules 10 Code words (11 Modules per code word) 110 modules Quiet zone (left) 10 modules Quiet zone (right) 10 modules Total 165 modules Given minimum module width of > 0.17 mm x 165 = 28.05 mm minimal code length scanware Track & Trace Solutions The systems of the product family LYNX-CAPA are designed for the packaging process in regard to Track & Trace requirements. Single and multiple units are marked or labeled and verified. The processing of serialised data is handled by the scanware DataHandler. The scanware Benefits ▪ Modular built for a multitude of installation options ▪ Real-time operating system QNX® for security and speed ▪ Uniform graphical interface and easy-to-follow menu structure ▪ Fully 21 CFR Part 11 compliant ▪ Hard- and software are expandable and upgradable ▪ Wear-free, electronically controllable scanware W-LED illumination ▪ Easy to install on all common packaging machinery ▪ Communication with machine via a VDMA-XML protocol ▪ Simultaneous use of numerous inspection parameters ▪ Variety of statistical tools LYNX-SPECTRA Product Inspection LYNX-SIGNUM Code Inspection LYNX-FOCON Pore Inspection LYNX-CAPA Track & Trace Solutions scanware electronic GmbH Darmstädter Straße 9-11 D-64404 Bickenbach Telephon +49 6257 9352-0 Fax -22 [email protected] www.scanware.de ▪ Development of special tasks and requirements on your request ▪ Availability of all parts guaranteed for 10 years ▪ Service offering solutions and support within 24 hours Quality is visible. International Distributors: Algeria | Brazil | Canada | Denmark | France | Ireland Italy | Jordan | Mexico | Morocco | Norway | Puerto Rico South Korea | Spain | Sweden | Switzerland | Tunisia United Kingdom | United States © scanware electronic GmbH 2014 Start trigger Disclaimer This brochure contains information on legislation concerning Track & Trace regulations in a number of countries. This information was correct at the date of publication. However, it does not constitute a legal guideline and the information is subject to change. Although we have taken pains to provide you with accurate information, scanware electronic GmbH disclaims all responsibility for errors and omissions in this information. Calculation of China E-Code Length
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