How are forwarders addressing the demands of shippers for cost effective air distribution of pharmaceuticals?

An introduction to Pharmafreight 1 2 3 4 5 6 7 Established back in 2001 Part of Mach 2 Group World alliance of 25 freight companies Specialists in pharma logistics UK operation has its own WDA Temperature controlled facility at LHR Operating to GDP

Transportation what does GDP state? Chapter 9 Responsibility of supplying wholesaler to ensure temperatures maintained during transport Risk-based approach Vehicles and equipment used suitable for use and appropriate Dedicated vehicles used where possible Outsourced activities should be defined, agreed and controlled Selection of packaging based on storage and transportation requirements of the product Vehicles should be temperature mapped and equipment calibrated

How things have changed Then vs now GDP Guidelines was over eight pages in Orange Guide - now 23 pages Regulatory focus was on cold chain and warehouses now CRT and transport chain Airline specialists used to be KLM and LH now more than 20 airlines have pharma products Ambient vs Controlled Ambient - biggest requirement now is +15 to +25 Water-based temperature controlled disposable packaging now reusable VIP shippers Companies want to work with specialists or those which have know-how

Look beyond Active How to create cost-effective air solutions Big Pharma is here, but so are thousands of other WDA Holders Positive rise in airline pharma products Water-based TC packaging vs reusable solutions e.g. Credo Passive containers e.g. Va-Q-Tec and TOWER KTM C Safe vs Envirotainer Thermo pallet covers Final mile in thermo vehicles

Choosing the right solution Size How much product to be shipped? Value Generic or branded? Product and use What will it be used for? E.g. orphan drug in clinical trial

Choosing the right solution Destination Tricky import? Long transit time? Temperature requirement Temperature characteristics of product e.g. 2-8, 15-25, - 20, -60 to -80, -120 Risk Using risk assessment what will happen, how likely and effect?

Commercial vs Quality Which wins? Shipments of the same product using different methods Paying the top price doesn t guarantee success Move from Active to Passive Use of Risk do we have access to stability data? Urgent use for the product, e.g. clinical trial? Route Qualification understanding what challenges shipments face Working with trusted critical partners Consider: Supplier qualification Risk Assessment Quality Technical Agreement Audit

Is the aircraft temperature-mapped? Managing expectations Shippers expectations can be unrealistic Misconception everyone works to a GMP/GDP standard Temperature range shown on paperwork? Make it happen! Knowledge gaps in transport industry need to be managed Sometimes no alternative than to ship in non-gdp environment

Call it 10, and I want change The effect of price reduction Some shippers want full compliance until they hear the cost Forwarders and their partners need to cater for all parts of the industry trader to MFR Cheaper packaging solutions and quicker transit times Low cost carriers - no frills We are not here to police the industry ultimately the customer knows more than us However remember the patient in all of this! At some point the Quality ceases to exist

What s next? Future trends Increasing specialist providers, e.g. rise in thermo truck services Developments in reusable packaging, hub systems Enhancements to airline pharma services, e.g. airline TC dollies, CEIV Real-time temperature track and trace New drug products with increased TC requirements biotech and comparators Global reach of GDP