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Pharmaceutical wholesaler

Pharmaceutical wholesaler. Gergely ZAJZON MD. Semmelweis University, EKK Egészségügyi Informatikai, Fejlesztő és Továbbképző Intézet. Distribution chain. Manufacture Pharmaceutical wholesaler Public Pharmacy Institutional Pharmacy (Hospital,etc.) Other shops selling OTC products.

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Pharmaceutical wholesaler

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  1. Pharmaceuticalwholesaler Gergely ZAJZON MD Semmelweis University, EKKEgészségügyi Informatikai, Fejlesztő és Továbbképző Intézet

  2. Distribution chain • Manufacture • Pharmaceutical wholesaler • Public Pharmacy • Institutional Pharmacy (Hospital,etc.) • Other shops selling OTC products Transport Transport

  3. GDP • Good Distribution Practice (GDP) is that part ofquality assurance which ensures that products areconsistently stored, transported and handled undersuitable condition as required by the marketingauthorization (MA) or product specification - MHRA, UK - DR. ZAJZON GERGELY

  4. Distribution chain GMP • Manufacture • Pharmaceutical wholesaler • Public Pharmacy • Institutional Pharmacy (Hospital, etc.) • Other shops selling OTC products Transport GDP Transport

  5. GMP • Good Manufacturing Practice is that part of Quality Assurance whichensures that products are consistentlyproduced and controlled to the qualitystandards appropriate to their intended useand as required by the marketing authorization or product specification DR. ZAJZON GERGELY

  6. GMP vs. Distribution The nature of the risks involved may generally,however, be the same as those in the manufacturing environment e.g mix-ups, contamination and cross contamination There are thus aspects in distribution to whichthe principles of GMP should be applied These include, but are not limited to, storage,distribution, transportation, packaging, labeling,documentation and record-keeping practices. DR. ZAJZON GERGELY

  7. GMP vs. Distribution Chapter 1 • requires satisfactory arrangements for storage and distribution to maintain quality Chapter 4 • requires batch distribution records to be kept Chapter 5 • deals with storage after release and the handling ofproduct returned from the market Chapter 8 • deals with product complaints and recalls DR. ZAJZON GERGELY

  8. INTERNATIONAL DISTRIBUTION CHAIN DR. ZAJZON GERGELY

  9. DR. ZAJZON GERGELY

  10. Products distributed DR. ZAJZON GERGELY

  11. Products distributed • Medicine • Food supplement • Medical device

  12. Wholesaler activities • Storage of medicines • Temperature control • Clean, safe environment (no pesticides, dry place, etc.) • Shelf life control • Transportation of medicines • Quality assurance • Counterfeit medicines DR. ZAJZON GERGELY

  13. Quality Management System SOP • Standard Operation Procedure • Rules governing the different activities of the pharmaceutical wholesaler • Exact definition of • The activity (procedure to be followed) • The responsibilites DR. ZAJZON GERGELY

  14. Quality Assurance Checking the products arriving: • Correct transportation • Certificate of Conformance / Analysis from Seller /Manufacturer • Identifier: Product Name, Batch number on box vs. Documentation • Expiry Date (min. 6 months shelf life at buying, min 1-3 months at selling) • Correct information (box and PIL – leaflet) vs. Marjeting Authorisation (MA) • No counterfeit medicine DR. ZAJZON GERGELY

  15. IT System for Wholesaler Stock management • Quantity, Batch, Expiry date • FEFO = First Expiry First Out • Exact definition of storage spaces • Only one batch of one product can be stored at one space Quality Assurance Management DR. ZAJZON GERGELY

  16. IT System for Wholesaler Warehouse system • Order / Shipment from Seller • Order from Buyer • Electronic interface with pharmacy systems • Invoice Management • Picking list – choosing the right batches and quantity DR. ZAJZON GERGELY

  17. IT System for Wholesaler Built-In Alerts • Expiry date • Storage conditions • Temperature deviations • Quantity Management DR. ZAJZON GERGELY

  18. Product identification • Product name • Marketing Authorisation Number • Batch number • Expiry Date • Barcode • EAN • 2D (Matrix barcode) DR. ZAJZON GERGELY

  19. EAN Europaische Artikel Numerierung Barcode on the outer medicine packge EAN 13 structure: HUN COMPANY PRODUCT 5 997086 102917 CONTROL DIGIT Identifiesonlythepacksize of a medicine, nottheexactbox! DR. ZAJZON GERGELY

  20. 2D barcode – Data Matrix Advantage: • More information can be stroed than in linear barcode Disadvantage: • Linear barcode reader is not usable, extra cost in pharmacies DR. ZAJZON GERGELY

  21. 2D barcode – Data Matrix IDENTIFICATION LEVEL Unique identifier for each pacage of medincal product Tradename (Brand) + Dosage form + Strength Track & Trace systems +Packsize + Batch ? Exact box of medicine DR. ZAJZON GERGELY

  22. Track & Trace • Unique identifier • Printed at packagin line at the manufactuing site from given from the database of the manufacturer and reported to a central database • More information then in EAN: • Batch Nr. • Expiry date • Exact following method from manufacturer to patient during the whole supply chain DR. ZAJZON GERGELY

  23. Special thanks for the slides of • Muhammad Lukmani Ibrahim (NPCB, Ministry of Health, Malaysia) DR. ZAJZON GERGELY

  24. Thank you! GERGELY ZAJZON MD Assistant lecturer Mobile: +36-20-9604294 E-mail: zajzon.gergely@zazacom.hu Web: http://www.gyogyszerugy.hu DR. ZAJZON GERGELY

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