pharmaceutical wholesaler
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
Pharmaceutical Pharmaceutical wholesalerwholesaler
Gergely ZAJZON MDGergely ZAJZON MD
Semmelweis University, EKKSemmelweis University, EKKEgészségügyi Informatikai, Fejlesztő és Egészségügyi Informatikai, Fejlesztő és
Továbbképző IntézetTovábbképző Intézet
Distribution chain
• Manufacture
• Pharmaceutical wholesaler
• Public Pharmacy• Institutional Pharmacy (Hospital,etc.)• Other shops selling OTC products
Transport
Transport
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. DR. ZZAJZON AJZON GGERGELYERGELY
Distribution chain
• Manufacture
• Pharmaceutical wholesaler
• Public Pharmacy• Institutional Pharmacy (Hospital, etc.)• Other shops selling OTC products
Transport
Transport
GDP
GMP
GMP
• 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. DR. ZZAJZON AJZON GGERGELYERGELY
GMP vs. DistributionThe 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. DR. ZZAJZON AJZON GGERGELYERGELY
GMP vs. DistributionChapter 1• requires satisfactory arrangements for storage and
distribution to maintain qualityChapter 4• requires batch distribution records to be keptChapter 5• deals with storage after release and the handling of
product returned from the marketChapter 8• deals with product complaints and recalls
DR. DR. ZZAJZON AJZON GGERGELYERGELY
DR. DR. ZZAJZON AJZON GGERGELYERGELY
INTERNATIONAL DISTRIBUTION CHAIN
DR. DR. ZZAJZON AJZON GGERGELYERGELY
Products distributed
DR. DR. ZZAJZON AJZON GGERGELYERGELY
Products distributed
• Medicine• Food supplement• Medical device
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. DR. ZZAJZON AJZON GGERGELYERGELY
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. DR. ZZAJZON AJZON GGERGELYERGELY
Quality AssuranceChecking 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. DR. ZZAJZON AJZON GGERGELYERGELY
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. DR. ZZAJZON AJZON GGERGELYERGELY
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. DR. ZZAJZON AJZON GGERGELYERGELY
IT System for Wholesaler
Built-In Alerts• Expiry date• Storage conditions• Temperature deviations• Quantity Management
DR. DR. ZZAJZON AJZON GGERGELYERGELY
Product identification
• Product name• Marketing Authorisation Number• Batch number• Expiry Date• Barcode
– EAN– 2D (Matrix barcode)
DR. DR. ZZAJZON AJZON GGERGELYERGELY
DR. DR. ZZAJZON AJZON GGERGELYERGELY
EANEuropaische Artikel Numerierung
Barcode on the outer medicine packge
EAN 13 structure:EAN 13 structure:
5 997086 1029175 997086 102917
HUN COMPANY PRODUCT
CONTROL DIGIT
Identifies only the packsize of Identifies only the packsize of a medicine, not the exact box!a medicine, not the exact box!
DR. DR. ZZAJZON AJZON GGERGELYERGELY
2D barcode – Data Matrix
Advantage:• More information can be stroed than in
linear barcodeDisadvantage:• Linear barcode reader is not usable, extra
cost in pharmacies
DR. DR. ZZAJZON AJZON GGERGELYERGELY
+ Strength
+Packsize
+ Batch
+ Dosage form
Tradename (Brand)
IDENTIFICATION LEVEL
Exact box of medicine ?
2D barcode – Data MatrixUnique identifier for
each pacage of medincal product
Track & Trace systems
DR. DR. ZZAJZON AJZON GGERGELYERGELY
Track & TraceTrack & 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
Special thanks for the slides of
• Muhammad Lukmani Ibrahim(NPCB, Ministry of Health, Malaysia)
DR. DR. ZZAJZON AJZON GGERGELYERGELY
DR. DR. ZZAJZON AJZON GGERGELYERGELY
Thank you!
GERGELY ZAJZON MDAssistant lecturerMobile: +36-20-9604294E-mail: [email protected]: http://www.gyogyszerugy.hu