Advancing GDP Compliance Standards In Airline Transportation: Raising the QA Bar for Biopharma. Chris Fore Compliance Manager

Transcription

1 Advancing GDP Compliance Standards In Airline Transportation: Raising the QA Bar for Biopharma Chris Fore Compliance Manager 9th BSMA Conference Foster City, CA 10/20/2016

2 Introduction There has been an increase in the number of air carriers with cold chain services 2016 = = = 7

3 Introduction There has been an increase in the number of air carriers with cold chain services

4 Introduction Forwarders have developed their pharmaceutical transportation services

5 Introduction There has been continued development and harmonization of GDP requirements

6 Introduction The industry has accepted third party standards

7 Transport service provider s quality obligations Parenteral Drug Association Technical Report # 39 (2007) International Conference on Harmonization Guidance for Industry Q10 Pharmaceutical Quality System International Organization for Standardization

8 Cost of Quality The Iceberg Model Cost of Poor Quality Internal Failures External Failures Cost of Good Quality Appraisal Costs Prevention Costs (1) The Iceberg Model of Cost of Quality

9 Evaluating quality Virtual Onsite Questionnaires Data Quality Agreements Trust but verify Personal 3rd Party

10 Assessing vendor quality What to consider Management controls

11 Assessing vendor quality What to consider Management controls Processes

12 Assessing vendor quality What to consider Management controls Processes CAPA

13 Assessing vendor quality What to consider Management controls Procedures CAPA Risk management

14 Assessing vendor quality What to consider Management controls Procedures CAPA Risk management

15 Training and education An extremely important, yet often neglected, GDP requirement Conduct regular, periodic training of personnel (1) Regular, periodic training of transport service provider personnel as well as sub-contractor personnel should be carried out. Training should be documented (2) (1) IATA Perishable Cargo Regulations Chapter 17 Section (2) Parenteral Drug Association Technical Report # 39 Section

16 Training and education We advocate GDP through a number of initiatives Free online courses for industry stakeholders 4% 250 Used by over 8,000 learners from 200 companies 20% 39% % Number of Learners Forwarder Ground Handler Airline Manufacturer 50 0 ORD FRA SVO BOM NRT AMS LHR SFO JFK ATL DFW ICN SIN LAX BRU PVG ZRH BSL AUH CDG DOH PHL DXB YYZ MEL BLR BOS DUB DEL LUX SYD PEK DUS MIA BUD SJU LIS HKG SEA GRU HEL VIE HYD MXP MAN YUL MAA TPE EZE GVA Top 50 cities

17 Training and education We advocate GDP through a number of initiatives Ground Services Award recognizes ground handlers trained in good cold chain practices

18 Training and education We advocate GDP through a number of initiatives Posters distributed to airport warehouses around the world to serve as training aids

19 Training and education We advocate GDP through a number of initiatives We provide ground handling agents with videos to train stakeholders on Good Distribution Practices

20 Training and education We advocate GDP through a number of initiatives In association with the BSMA and industry stakeholders, we are developing courses that will set new standards. Transportation Qualification Packaging Qualification Clinical Trials Good Distribution Practices Packaging Types Air Freight Logistics expert advanced Pharmaceutical Industry Quality Agreements and SOPs Risk Assessment basic

21 Call to action Promote quality with in your organization By periodically assessing quality, you can reduce costs and lead the market in delivering outstanding patient care on time, every time. Questions? Comments?