Regulatory aspect of barcode technology

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Regulatory aspect of barcode technology ( Introduction, FDA rule, Benefits of barcode, terminology, Symbologies, Types of barcode, Pharmacode, Applications of barcode, Types of barcode readers,Pharmaceutical)

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  • Dear Davesh,
    thanks for sharing it is interesting. So, as I understand this, this system is operational in the US since 2006 (system for checking that health workers are giving the right dose etc...)?
    I am organizing a workshop on the topic of traceability, how it is used in regulations, to manage risks.
    See if it is of interest to you:
    http://www.unece.org/tradewelcome/areas-of-work/working-party-on-regulatory-cooperation-and-standardization-policies-wp6/sessions/wp6-meetings/wp6-other-events/2011/workshop-on-traceability-a-tool-for-managing-risks/home-workshop-on-traceability.html
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Regulatory aspect of barcode technology

  1. 1. Regulatory aspect of Barcode technology<br />PRESENTED BY<br />DEVESH SHARMA<br />M.PHARM (DRA)<br />devesh.m.pharmdra@gmail.com<br />
  2. 2. Introduction<br />A barcode is an optical machine-readablerepresentation of data, which shows data about the object to which it attaches<br />Originally, barcodes represented data by varying the widths and spacings of parallel lines, and may be referred to as linear or 1 dimensional (1D).<br />Later they evolved into rectangles, dots, hexagons and other geometric patterns in 2 dimensions (2D). <br />
  3. 3. Barcodes originally were scanned by special–optical scanners called barcode readers, scanners and interpretive software are available on devices including desktop printers and smart phones.<br />The very first scanning of the now ubiquitous Universal Product Code (UPC) barcode was on a pack of Wrigley Company chewing gum in June 1974.<br />
  4. 4. FDA Rule: Bar Code Label Requirements forHuman Drug Products and Blood<br />All blood products, prescription drugs and OTC drugs commonly used in hospitals and dispensed pursuant to an order are source-coded with a linear bar code.<br />The bar code contains the National Drug Code number. It may also include other information (lot, expiration date, etc.) at the discretion of the manufacturer.<br />The bar code on blood products contains a unique facility identifier, lot number relating to donor, product code and blood type of donor.<br />
  5. 5. The bar code is visible on single dose packaging and all outer packaging.<br />This bar code will be part of a system that enables health care workers to check whether they are giving the right drug via the right dose and right route of administration to the right patient at the right time.<br />New drugs must comply with the rule within 60 days of approval, and existing drugs must comply by February 25,2006.<br />
  6. 6. Benefits of Barcode<br />REPRESENT UNIQUE IDENTITY OF A PRODUCT<br />ACCURACY OF DATA INPUT (ERROR FREE)<br />AID EFFECTIVE MANAGEMENT OF RESOURCES AND INVENTORIES<br />LABOUR SAVINGS BY AVOIDING MANUAL SYSTEM<br />COST EFFICIENT<br />REAL TIME DATA COLLECTION<br />MEASUREMENT OF WORK IN PROGRESS THROUGHOUT THE FACTORY<br />RAPID ACCESS TO TOTAL PRODUCTION COSTS<br />MORE ACCURATE DESPATCH<br />
  7. 7. Bar Code Terminology<br />BAR<br />The darker, non reflective element of a Bar Code<br />BI-DIRECTIONAL SYMBOL<br /> A Bar Code symbol format which permits reading in either direction <br /> across the bars and spaces<br />CHECK DIGIT<br /> A calculated character included within the Bar Code for error detection<br />FIXED BEAM SCANNER<br /> A stationary Bar Code Scanner. The symbol must be moved through <br /> the light beam to be read<br />HAND-HELD SCANNER<br /> A scanner held and operated by a human operator<br />
  8. 8. INTER-CHARACTER GAP<br />The space between the bars or spaces<br />MOVING BEAM SCANNER<br />A Bar Code scanner that uses a moving light beam to dynamically scan <br />and decode a Bar Code symbol<br />SPACE<br />The lighter, reflective element of a Bar Code<br />START CHARACTER<br />A special pattern of bars and spaces used to identify the beginning of a <br />Bar Code symbol<br />STOP CHARACTER<br />A special pattern of bars and spaces used to identify the end of a <br />Bar Code symbol<br />
  9. 9. Symbologies<br />A bar code symbol is a parallel arrangement of varying width bars and spaces.<br />"Symbology" is the term used to describe the clear rules specifying the way that data is encoded into the bar and space widths.<br />Symbology Type<br /><ul><li>Discrete Symbology
  10. 10. Continuous Symbology</li></li></ul><li>Discrete Symbology<br />In a discrete code, each character can stand alone and can be decoded independently from the adjacent characters. Each character is separated from its neighbour by loosely tolerancedintercharacter gaps, which contain no information. Every character has a bar on each end. In the decoding process, each character is treated individually. <br />Because the intercharacter gaps are loosely toleranced, a discrete code can be printed by a variety of different techniques. A discrete code can easily be produced by a printer that prints an entire character at one time, such as a movable font device.<br />
  11. 11. Continuous Symbology<br />A continuous code has no intercharacter gaps. Every character starts with a bar and ends with a space or vice versa, as shown in Figure 0-3 : Continuous Symbology. The end of one character is indicated by the start of the next character.<br />In a continuous bar code symbology there are no intercharacter gaps. Every character begins with a bar and ends with a space. Some form of termination pattern starting with a bar must provide the last “edge of next character” for the symbol's last character.<br />
  12. 12. Since there are no intercharacter gaps, a continuous code requires less symbol length to encode a given amount of data. Offsetting this density advantage is the fact that the range of available demand printing technologies is more restricted for continuous codes than it is for discrete symbologies.<br />
  13. 13. Discrete Symbology<br />Continuous Symbology<br />
  14. 14. Different Types of Barcodes<br />Pharmaceutical barcode types<br /><ul><li>2D Pharma Code - based on Data Matrix with colour fields
  15. 15. Binary Code - can colour bars individually
  16. 16. GlaxoSmithKline- variations of Pharma Code, EAN 13, EAN </li></ul> 8, Code 39 and MSI used by GSK<br /><ul><li>HIBC- specific applications using Code 39, Code 128 and </li></ul> EAN 128 <br /><ul><li>IKS - variation of EAN 13 used in Switzerland
  17. 17. IMH - variation of Code 39 used in Italy
  18. 18. Kurandt - you can specify number of bars
  19. 19. Novartis Pharma- variation of Pharma Code used by </li></ul> Novartis<br /><ul><li>Pharma Code - can colour bars individually
  20. 20. PZN - variation of Code 39 used in Germany </li></li></ul><li>Numeric-only barcodes<br /><ul><li>Codabar:  Older code often used in library systems, sometimes in blood banks
  21. 21. Code 11:  Used primarily for labeling telecommunications equipment
  22. 22. EAN-13:  European Article Numbering international retail product code
  23. 23. EAN-8:  Compressed version of EAN code for use on small products
  24. 24. Industrial 2 of 5:  Older code not in common use
  25. 25. Interleaved 2 of 5:  Compact numeric code, widely used in industry, air cargo
  26. 26. MSI:  Variation of the Plessey code commonly used in USA
  27. 27. Plessey:  Older code commonly used for retail shelf marking
  28. 28. PostNet:  Used by U.S. Postal Service for automated mail sorting
  29. 29. UPC-A:  Universal product code seen on almost all retail products in the USA and Canada
  30. 30. Standard 2 of 5:  Older code not in common use
  31. 31. UPC-E:  Compressed version of UPC code for use on small products </li></li></ul><li>Alpha-numeric barcodes<br /><ul><li>Code 128:  Very capable code, excellent density, high reliability; in very wide use world-wide
  32. 32. Code 39:  General-purpose code in very wide use world-wide
  33. 33. Code 93:  Compact code similar to Code 39
  34. 34. LOGMARS:  Same as Code 39, this is the U.S. Government specification </li></li></ul><li>2-Dimensional barcodes<br /><ul><li>PDF417:  Excellent for encoding large amounts of data
  35. 35. DataMatrix:  Can hold large amounts of data, especially suited for making very small codes
  36. 36. Maxicode:  Fixed length, used by United Parcel Service for automated package sorting
  37. 37. QR Code:  Used for material control and order confirmation
  38. 38. Data Code
  39. 39. Code 49
  40. 40. 16K </li></li></ul><li>Industry Standards for Barcodes and Labels<br /><ul><li>Bookland EAN encodes ISBN numbers, used internationally to mark books
  41. 41. ISSN and the SISAC Barcode:   International Standard Serial Numbering
  42. 42. OPC:  Optical Industry Association barcode for marking retail optical products
  43. 43. UCC/EAN-128:  Widely used data formatting model for Code 128
  44. 44. UPC Shipping Container Symbol:  ITF-14.</li></li></ul><li>Publishing barcode types <br /><ul><li>SAIN - for audiovisual works
  45. 45. ISBN - including EAN Bookland, UPC Price Point, Item Specific; 10-digit numbers supported for reprints
  46. 46. ISMN - for sheet music
  47. 47. ISSN - for newspapers and magazines
  48. 48. SISAC - for serial publications </li></li></ul><li>Postal barcode types<br /><ul><li>Four State - used in UK and some other countries
  49. 49. Post Net + Zip - used in USA; includes FIM code </li></ul>Proprietary retail barcodes<br /><ul><li>ASDA 13 - based on EAN 13, used by ASDA in UK
  50. 50. ASDA 8- based on EAN 8, used by ASDA in UK
  51. 51. MS7 - based on EAN 8, used by Marks and Spencer in UK
  52. 52. Wickes 8- based on EAN 8, used by Wickes in UK
  53. 53. Woolworth 8 - based on EAN 8, used by Woolworth in South Africa.</li></li></ul><li>Pharmacode<br />Pharmacode, also known as Pharmaceutical Binary Code, is a barcode standard, used in the pharmaceutical industry as a packing control system. It is designed to be readable despite printing errors. <br /> It can be printed in multiple colors as a check to ensure that the remainder of the packaging (which the pharmaceutical company must print to protect itself from legal liability) is correctly printed.<br />
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  62. 62. Barcode Reader<br />A barcode reader (or barcode scanner) is an electronic device for reading printed barcodes. <br />It consists of a light source, a lens and a light sensor translating optical impulses into electrical ones.<br />
  63. 63. Types of barcode readers<br />Pen-type readers<br />Laser scanners<br />CCD readers<br />Camera-based readers<br />Omni-directional barcode scanners<br />Cell phone cameras<br />
  64. 64. Reference<br />Automating Management Information Systems: Barcode Engineering and Implementation – Harry E. Burke, Thomson Learning, ISBN 0-442-20712-3 <br />Automating Management Information Systems: Principles of Barcode Applications – Harry E. Burke, Thomson Learning, ISBN 0-442-20667-4<br />The Bar Code Book – Roger C. Palmer, Helmers Publishing, ISBN 0-911261-09-5, 386 pages <br />The Bar Code Manual – Eugene F. Brighan, Thompson Learning, ISBN 0-03-016173-8<br />Handbook of Bar Coding Systems – Harry E. Burke, Van Nostrand Reinhold Company, ISBN 978-0-442-21430-2, 219 pages <br />Information Technology for Retail:Automatic Identification & Data Capture Systems - Girdhar Joshi, Oxford University Press, ISBN 0-19-569796-0, 416 pages <br />Lines of Communication – Craig K. Harmon, Helmers Publishing, ISBN 0-911261-07-9, 425 pages <br />Punched Cards to Bar Codes – Benjamin Nelson, Helmers Publishing, ISBN 0-911261-12-5, 434 pages <br />Revolution at the Checkout Counter: The Explosion of the Bar Code – Stephen A. Brown, Harvard University Press, ISBN 0-674-76720-9 <br />Reading Between The Lines – Craig K. Harmon and Russ Adams, Helmers Publishing, ISBN 0-911261-00-1, 297 pages <br />
  65. 65. The Black and White Solution: Bar Code and the IBM PC – Russ Adams and Joyce Lane, Helmers Publishing, <br /> ISBN 0 911261-01-X, 169 pages <br />12. Sourcebook of Automatic Identification and Data Collection – Russ Adams, Van Nostrand Reinhold, SBN 0-442-<br /> 31850-2, 298 pages <br />13. Alan Haberman, Who Ushered In the Bar Code, Dies at 81. // The New York Times, 15.06.2011<br />Fishman, Charles (August 1, 2001). "The Killer App - Bar None". American Way. http://www.americanwaymag.com/so-woodland-bar-code-bernard-silver-drexel-university. Retrieved 2010-04-19.<br />Tony Seideman, "Barcodes Sweep the World", barcoding.com Wonders of Modern Technology<br />George Laurer, "Development of the U.P.C. Symbol", bellsouthpwp.net<br />Nelson, Benjamin (1997). From Punched Cards To Bar Codes.<br />Varchaver, Nicholas (2004-05-31). "Scanning the Globe". Fortune. http://money.cnn.com/magazines/fortune/fortune_archive/2004/05/31/370719/index.htm. Retrieved 2006-11-27.<br />Selmeier, Bill (2008). Spreading the Barcode. pp. 26, 214, 236, 238, 244, 245, 236, 238, 244, 245. ISBN 978-0-578-02417-2.<br />http://www.av1611.org/666/barcode.html<br />
  66. 66. 21. Bishop, Tricia (July 5, 2004). "UPC bar code has been in use 30 years". SFgate.com. http://www.sfgate.com/cgibin/article.cgi?file=/chronicle/archive/2004/07/05/BUG6Q7G4AJ1.DTL&type=business. Retrieved 22 December 2009.<br />22. "GS1 Bar Code Verification for Linear Symbols". Global Standards 1 (4.3): 23–32. May 2009. http://www.gs1.org/docs/barcodes/GS1_Bar_Code_Verification.pdf. Retrieved 2 August 2011.<br />23. Harmon and Adams(1989). Reading Between The Lines, p.13. Helmers Publishing, Inc, Peterborough, New Hampshire, USA. ISBN 0911261001.<br />24. FDA.gov, Health Industry Bar Code (HIBC) supplier labeling standard<br />25. Russ Adams (2009-06-15). "2-Dimensional Bar Code Page". http://www.adams1.com/stack.html. Retrieved 2011-06-06.<br />26. "Barcodes for TV Commercials". Adverlab.blogspot.com. 2006-01-31. http://adverlab.blogspot.com/2006/01/barcodes-for-tv-commercials.html. Retrieved 2009-06-10.<br />27. "BarCode-1 2-Dimensional Bar Code Page". Adams1.com. http://www.adams1.com/pub/russadam/stack.html. Retrieved 2009-06-10.<br />28. "Handheld barcode scanner technologies, illustrated". http://www.denso-wave.com/en/adcd/fundamental/barcode/scanner.html.<br />29. Katanshi Barcode Reader webcam based barcode reader<br />30. Barcode reading apps for enterprise, codeREADr.com, 2010<br />
  67. 67. THANKS<br />

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