How does the GDP guidelines impacted DGF on Local and Global level. 25 june 2013

Transcription

1 How does the GDP guidelines impacted DGF on Local and Global level. 25 june 2013

2 Overview Introduction Who is DHL? What is GDP? DGF services Global approach DGF services Belgium 2

3 Introduction Elledin Djernoune (Life Sciences & Healthcare Product Manager) DHL Global Forwarding (Belgium) NV/SA Building 830 B-1931 Brucargo (BRU) direct phone : direct fax : mobile : years sales in the Logistic/ Air & Ocean transportation Industry. 10 years in the Life Sciences & Health Care Industry at DHL Global Forwarding. 3

4 Introduction - DPDHL DPDHL group with a global network and the logistics portfolio Employees: ~ 475,000 / Revenue: EUR 55.5bn 1) Employees: ~ 175,000 / Revenue: EUR 13.9bn Die Post für Deutschland Employees: ~ 285,000 / Revenue: EUR 40.0bn The Logistics Company for the World EXPRESS GLOBAL FORWARDING & FREIGHT SUPPLY CHAIN International Express Air and Ocean Freight Road Freight Contract Logistics & Business Process Outsourcing 1) Excluding Corp. Center/Other/Consolidation = EUR 1.2bn

5 Introduction - DHL 4

6 Introduction - DGF BE New Location as from January 21th, Total surface area: m² Warehouse m² X-Ray system Rollerbed system in the warehouse Temperature controlled area 2000 m² Office building m² (4 floors)

7 What is GDP? GDP (Gross Domestic Product) = C + I + G + (X M) is the market value of all officially recognized final goods and services produced within a country in a given period of time 7

8 What is GDP? GDP (Good Distribution Practice) = guidelines for the distribution of medicinal products for humans use. History : The guidelines are coming from WHO specifications The first guidelines in accordance of CD 92/25/EEG of 31March First publication in1994. Reviewed first time in 2011, based on Fasified Medicines. New GDP was necessary due to a more complex supply chains. (Mulitple origins, various destinations & transit...) 07 March

9 What is GDP? 2013/C 68/01 & new areas Chapter 1: Quality Management- New areas are: CAPA, Change Control, and Risk Management for distributors. Chapter 2: Personnel / Training- New areas are: responsible Responsible Person =continuous contactable, Involved staff has regular training. Chapter 3: Premises & Equipment / Qualification & Validation New areas are: record (maintenance, calibration) retention, qualifications of equipment and computer syst. validation. Chapter 4: Documentation New areas are : Documentation in language understood by the personnel, periodic review and version control. Chapter 5: Operations / Supplier Management New areas are: expands on requirements incl. provisions for improving supplier management as well as bona fide verification. 9

10 What is GDP? 2013/C 68/01 & new areas Chapter 6: Compliant Handling - (Addresses complaints, returns, counterfeiting and product recalls.) Chapter 7: Outsourced Activities / Supplier Management-- Introduces controls for outsourcing GDP activities (use of sub-contractors). Chapter 8: Internal Audits- New areas are : independency of the auditors including provisions for internal audits and use of the CAPA system for dealing with corrective actions resulting from the audit. Chapter 9: Transportation New areas are : Medicines to be shipped within label conditions, Describes new provisions for transportation including requirements for shipments, contract for carriers, dedicated vehicles, and risk assessment for transportation routes., Temperature excursions being filed and investigation Chapter 10: Broker Requirements- New provision including requirements for brokers. 10

11 GDP Temperature controlled rooms Ambient Warehouse Not in Europe Temp controlled warehouse in an African country 11

12 DGF - Belgium approach VAS Usage of insulated packaging Temperature monitoring Taylor made (air solutions) Infrastructure Equipment Processes Scope of Service Processes LSH compliant responsible 12

13 DHL - Global Services Proprietary DHL SMARTSENSOR Technology (SST) will be used for DHL THERMONET shipments Possibility to extend this with Janssen Brazil, if Scan if used with full LifeTrack integration SmartSensors and DHL THERMONET RFID One SmartSensor RFID per shipment (HAWB) Ambient temperature monitored as standard Attach and Start of SST at DGF Export LSCC Last temperature read at DGF Import LSCC SST will stay with shipment until POD LSCCs will be equipped with 3 SST Mobile Reader LSCCs will hold a small stock of SSTs Temperature data automatically send to LifeTrack No temperature visibility for customers before POD SST Mobile Readers can operate with FSI WiFi Network or GSM SIM Card needed on-site to operate SST Mobile Reader SmartSensor RFID Technology Integrated to LifeTrack SmartSensor RFID Wireless SmartSensor Mobile Reader Upload LifeTrack Time Savings: Temperature data available within seconds after upload Individual Tracking: Sensors can be linked to individual HAWBs and MAWBs Plug and Play Solution: No software installation needed, sensors pre-programmed and ready to use GDP compliant: Fulfils regulations EU GMP Annex 11, US 21 CFR Part 11 and EU GDP

14 DGF - Belgium approach Real-time monitoring solution for highervalue air freight shipments Used within DHL aviation network Trials several shipments (passive and active packaging) Pre mature test results, Overall Satisfactory results (over the entire process apt to apt) DHL Global Forwarding Central Eastern Europe I October 2012 XX

15 Q & A Life Science - Amla IIS May