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

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


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.


GMP vs. DistributionChapter 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



INTERNATIONAL DISTRIBUTION CHAIN


Products distributed


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


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


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


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



Warehouse system

• Order / Shipment from Seller

• Order from Buyer– Electronic interface with pharmacy systems

• Invoice Management

• Picking list – choosing the right batches and quantity



Built-In Alerts

• Expiry date

• Storage conditions

• Temperature deviations

• Quantity Management


Product identification

• Product name

• Marketing Authorisation Number

• Batch number

• Expiry Date

• Barcode– EAN– 2D (Matrix barcode)



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!


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


+ 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


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)



Thank you!

GERGELY ZAJZON MDAssistant lecturer

Mobile: +36-20-9604294

E-mail: [email protected]

Web: http://www.gyogyszerugy.hu

mailto:[email protected]

http://www.gyogyszerugy.hu/

Documents

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