1. Pharmaceutical wholesaler Gergely ZAJZON MD Semmelweis University, EKK Egészségügyi Informatikai, Fejlesztő és Továbbképző Intézet

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

3. GDP Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorization (MA) or product specification - MHRA, UK - DR. Z AJZON G ERGELY

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

5. Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification DR. Z AJZON G ERGELY

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 which the principles of GMP should be applied These include, but are not limited to, storage,distribution, transportation, packaging, labeling,documentation and record-keeping practices. DR. Z AJZON G ERGELY

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 of product returned from the market Chapter 8 deals with product complaints and recalls DR. Z AJZON G ERGELY

8. INTERNATIONAL DISTRIBUTION CHAIN

9. DR. Z AJZON G ERGELY

10. Products distributed DR. Z AJZON G ERGELY

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. Z AJZON G ERGELY

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. Z AJZON G ERGELY

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. Z AJZON G ERGELY

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. Z AJZON G ERGELY

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. Z AJZON G ERGELY

17. IT System for Wholesaler Built-In Alerts Expiry date Storage conditions Temperature deviations Quantity Management DR. Z AJZON G ERGELY

18. Product identification Product name Marketing Authorisation Number Batch number Expiry Date Barcode –EAN –2D (Matrix barcode) DR. Z AJZON G ERGELY

19. EAN Europaische Artikel Numerierung Barcode on the outer medicine packge EAN 13 structure: 5 997086 102917 HUN COMPANYPRODUCT CONTROL DIGIT Identifies only the packsize of a medicine, not the exact box!

20. DR. Z AJZON G ERGELY 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

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

22. DR. Z AJZON G ERGELY 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

23. Special thanks for the slides of Muhammad Lukmani Ibrahim (NPCB, Ministry of Health, Malaysia) DR. Z AJZON G ERGELY

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