Pharmaceutical
wholesaler
Gergely ZAJZON MD
Semmelweis University, EKK
Egészségügyi Informatikai, Fejlesztő és
Továbbképző Intézet
Distribution chain
• Manufacture
Transport
• Pharmaceutical wholesaler
Transport
• Public Pharmacy
• Institutional Pharmacy (Hospital,etc.)
• Other shops selling OTC products
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. ZAJZON GERGELY
Distribution chain
• Manufacture
GMP
Transport
• Pharmaceutical wholesaler
GDP
Transport
• Public Pharmacy
• Institutional Pharmacy (Hospital, etc.)
• Other shops selling OTC products
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. ZAJZON GERGELY
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. ZAJZON GERGELY
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. ZAJZON GERGELY
INTERNATIONAL
DISTRIBUTION CHAIN
DR. ZAJZON GERGELY
DR. ZAJZON GERGELY
Products distributed
DR. ZAJZON GERGELY
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. ZAJZON GERGELY
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
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
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
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
IT System for Wholesaler
Built-In Alerts
• Expiry date
• Storage conditions
• Temperature deviations
• Quantity Management
DR. ZAJZON GERGELY
Product identification
•
•
•
•
•
Product name
Marketing Authorisation Number
Batch number
Expiry Date
Barcode
– EAN
– 2D (Matrix barcode)
DR. ZAJZON GERGELY
EAN
Europaische Artikel Numerierung
Barcode on the outer medicine packge
EAN 13 structure:
HUN
COMPANY
PRODUCT
5 997086 102917 CONTROL
DIGIT
Identifies only the packsize of
a medicine, not the exact box!
DR. ZAJZON GERGELY
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
2D barcode – Data Matrix
IDENTIFICATION LEVEL
Tradename (Brand)
+ Dosage form
Unique identifier for
each pacage of
medincal product
+ Strength
+Packsize
Track & Trace
systems
+ Batch
Exact box of medicine
?
DR. ZAJZON GERGELY
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
Special thanks for the slides of
• Muhammad Lukmani Ibrahim
(NPCB, Ministry of Health, Malaysia)
DR. ZAJZON GERGELY
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