K E t ti f thKey Expectations of the Transportation Supplier from Ph /Bi C iPharma/Bio Companies

Shirley Ann Feld, Associate Director Global Quality Transport IATA World Cargo Symposium 2010IATA, World Cargo Symposium 2010

sanofi-aventisGroup ProfileGroup Profile

# 4 worldwide

# 1 in Europe with double-digit growth in emerging markets

2008 l th € 28 billi2008 sales more than € 28 billion

World leader in vaccines

Nearly 100.000 employees in more than 100 countries

C 17600 l i R & DCa. 17600 employees in R & D

A broad portfolio of medicines

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More than 100 sites worldwide*

•80 Production sites

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•80 Production sites30 R&D sites 36 Distributions centers in 24 countries

Production sites worldwideRomainville

ElbeufLe Trait CompiègneLe Trait

GrangeSt.-Clair

Vitry

Ploermel

Compiègne

Maisons-Alfort

Amilly

Quétigny

Neuville

Lisieux

Riells CsanyikvölgyUjpest

VeresFawdon

Holmes ChapelDagenham

FrankfurtKöln

Laval

Ploermel

Tours

Ambarès

Mourenx

Colomiers

Neuvillesur SaôneVertolaye

Sisteron

Aramon

KawagoeSeoulPeking

HangzhouTongiKarachiWah

AnkleshwarO d S Tunis

CairoCyprèsZenata

Ain Sebaa

RiellsAlcobendas

AlcorconLoures

Anagni

ScoppitoGaressioMailandOriggio

Csanyikvölgy

OcoyoacacCuautitlan

Kansas CitySaint Louis

Colomiers

BandungJakarta

JurongHo Chi Minh CityGoa

DakarOued Smar Tunis

MegrineAnagni

BrindisiGuarenas

Cali

Guatemala City

Guadalupe WaltlooSuzano

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Therapeutic Areas and Major Products

CardiovascularDiabetesDiabetesThrombosis

Oncology

Central Nervous System

Internal Medicine

VaccinesInfluenza, Polio, Pertussis, MMR, Hepatitis A+B;Meningitis, Pneumonia; Booster vaccines for adults;Vaccines

OTCGenerics (Winthrop)

g , ; ;Travel (e.g.Yellow Fever) and other endemic vaccines

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K E t ti f thKey Expectations of the Transportation Supplier from Ph /Bi C iPharma/Bio Companies

Shirley Ann Feld, Associate Director Global Quality Transport IATA World Cargo Symposium 2010IATA, World Cargo Symposium 2010

Key Expectations of the Transportation Supplier

Contents

What is the target for Pharma/Bio companies?

Why is this so?Why is this so?

How do they expect to reach it?

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Key Expectations of the Transportation Supplier

The TargetMaintain the integrity of pharmaceutical products throughout the supply chain; in order to provide the product in the best quality to the customerthe product in the best quality to the customer (patient) so that it is safe, potent and effective

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Key Expectations of the Transportation Supplier

Why?By law we are expected to protect our customer (patients) from any quality deficiency caused by transportation and / or temperature failures or excursionsAs a company:

Reduce and minimize risk of product loss caused by unacceptable temperature deviations or physical damage when shipped to the markets

A id t f t kAvoid out of stockAvoid loss of market shareAvoid loss of image

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Key Expectations of the Transportation Supplier

How?Prevention of errors and risk in distribution

Understanding and complying with regulationsMake sure procedures are in compliance with the nationaland international requirements

Effective communicationBetween shipper and forwarder

Risk ManagementInvolves everyone

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Understanding and complying with regulations

Requirements / quality standards for Pharma companiesGxP (GMP GDP)GxP (GMP, GDP)

Europe driven by EU requirementsEU Directive 92/25/EEC, Guidance 94/C 63/03*“Guidelines on good distribution practice…”g p

US driven by 21 CFR and USPChapters on Stability, Storage TemperatureGeneral chapter <1079>* “Good storage and shipping practices”

Good Storage and Transportation Practices for Drug ProductsGood Storage and Transportation Practices for Drug Products

National requirementsWHO for rest of the world

“Good trade & distribution practices for pharmaceutical starting materials”Good trade & distribution practices for pharmaceutical starting materials“Good Storage Practices” (GSP)“GDP for Pharmaceutical Products”*Regulatory oversight…time + temperature sensitive pharma. prods. draft

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* Being revised

NEW – WHO pharmaceutical cold chain guideline (regulatory oversight)

1. Introduction 8. Transport and delivery

Main section headings Example 8. Transport and delivery covers

8.1 Normative references

2. Methodology 9. Stock Management

3. Importation 10. General procedures and record keeping

4. Warehousing sites 11. Labelling

8.2 Product stability profiles

8.3 Transport route profiling and qualification

8.4 Temperature controlled vehicles

8.5 Temperature and humidity control and monitoring during transit

5. Storage buildings 12. Environmental management

6. Temperature-controlled storage 13. Quality management

7. Materials handling 14. Personnel/training

8.6 Temperature-controlled vehicle validation

8.7 Calibration and verification of transport monitoring devices

8.8 Shipping containers

8.9 Shipping container packing

8.10 Product handling during packing and transport

8.11 Cleaning vehicles and transport containers

8.12 Transport of returned and recalled TSPPsProfile and qualify transport routes:•Select the most appropriate methods for protecting TSPPs against anticipated ambient temperature and humidity conditions encountered throughout the year.•Use appropriate methods including published standards weather data

TimeframeO 2009•Use appropriate methods, including published standards, weather data,

laboratory tests and field tests to select suitable transport equipment and shipping containers.

Reason: To ensure that TSPPs can safely be transported within the transport temperature profile defined for each product and that compliance can be demonstrated to the regulatory authorities and other interested parties.

WHO Review 2009Comments 2010Publication 2011/2012

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Understanding and complying with regulations

Requirements and quality standards for airfreightIATA Perishable Cargo Regulations 9th Ed Eff ti J l 9th 2009IATA Perishable Cargo Regulations 9th Ed. Effective July 9th 2009

Chapter 17:Air Transport Logistics for Temperature Sensitive Healthcare Products

PurposePurposeProvide information on the factors affecting the a.m.Indicate critical control points which may impact themProvide best practices for training, QMS, label etcp g, ,

Who is in the scopeProduct manufacturers, shippers, third party logistic providers, cargo agents, freight forwarders, indirect air carriers, airlines, packaging and l tf id h i t d h dl d t tplatform providers, warehousing agents, ground handlers and transport

service providers ………

Key expectation – read, understand and implement

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Effective communication

Suppositions by Pharma IndustryAll airports have

cold controlled room temperature

Pilot can adjust hold temperatures as requiredRamp personnel are airline

and freezer storage facilitiesStorage rooms / transit areas are not open to the weatherTh t

employeesSpecial instructions on airway bill are followed

The storage room temperatures are monitoredDry ice is always availableTime for loading or unloading

Ground-handling staff see AWBOffloaded goods are returned to WH

Time for loading or unloading less than 2 hoursCargo hold temperature is ca. +12 to +15 C

All staff are well trained to handle PFAll airfreight travels by air

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+12 to +15 C g y

Effective communication

Suppositions by Airfreight IndustryPharma freight (PF) is either

cold storage or Ambient/room temperature

PF should be treated as perishables Most PF is vaccines

storageRoom temperature means you don’t have to take special

ti

Insulated cartons should be placed in cold storageDuration of transport does

precautionsRoom temperature products are not temperature sensitive

not matterApprox. temperatures are OK

unaware of how critical PF always has storage labelingPF is easily identifiable

temperatures can beA container is a container is a container

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Effective communication

All players need to understand the distribution chain being used and its critical pointsbeing used and its critical points

Air

Pharma Manufacturer / DistributorTruck

PharmacyHospital…

Rail

Direct distribution

SeaProduct flow Pharma Wholesaler

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= manufacturer‘s Distributions center

Effective communication

Air freight

Domestic carrier

Air terminalDomestic carrier

Air terminalCarrier

Agent,t

Agent,tShipper Consignee

customs customsShipper

Ensure communication of correct information to every partner involved in the transport process viae.g. SOP, Service Level Agreement, Quality Agreement

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g g y g

Effective communication

Documentation between shipper and forwarder

Standard Shipping Instruction (SSI/SOP)

Defines in detail the conditions, transportation route, , p ,cooperation and communication between partners, e.g.

forwarder

departure airportdeparture airport

airline

onward carriage

destination airport

destination warehouse

d ring the shipping operation itself

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during the shipping operation itself

Risk Management

Involves everyone in the distribution chain

Utilization requiresAwareness of critical pointsAwareness of critical pointsQuality Management System…….

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Risk Management

Ti Ab T t AbAscertain critical points in air freight shipmentsTime Abuse

Excessive loading / unloading times

Temperature AbuseWrong storage temperatureWrong freight hold t tDelays due to:

Missed flightsChange in flight plansLanding diversions

temperatureStorage in direct sunlightStorage near open doorsE t t t tLanding diversions

Weather related delaysWrong destinationSecurity / customs checks

Extreme temperatures at:Warehouse / truckDock / rampAirport apron / tarmacy

Weekends / holidaysStrikes

Airport apron / tarmac

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Ref: IATA PCR 17.7 Key Risk Factors

Risk Management – Critical Points

Examples of Difficulties Encountered by Pharma/Bio Companies in Air FreightCompanies in Air Freight

Loading/unloading timesWrong storage

Split shipmentsOffloadingWrong storage

temperatureWrong freight hold temperature

OffloadingStopoversSecurity checksC t h ktemperature

Changes in flight plans:delaytechnical problems

Customs checksWeekends, bank holidaysHandling

technical problems cancellation

Wrong destination

Strikes

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Risk Management - Critical Points

Loading timesi.e. how long goods are outside on the tarmac before being loadede g Frankfurt Airporte.g. Frankfurt Airport 2 to 3 h3 to 6 h6 and more6 and more

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Risk Management - Critical Points

“Room” temperature goods, offloaded, waiting 4 days total

St d t id

Frankfurtth +23°CStored outside

at Frankfurt on aircraft pallet Flight to Brazil

Unloaded in Brazil

weather +23°C

TT data from 6 of 31 pallets:31 ll t > +30°CDeparts

shipperDeparts Roissy

Storage WH RoissyAirport WH Brazil

Consignee WH

31 pallets > +30°C24 pallets > +40°C16 pallets > +50°C9 pallets > +59°C

25.0

15 0

Stability data to +50°CLoss € 550 000

15.0

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Risk Management - Critical Points

Handling of room temperature products during stopover

Stopover in Doha QatarDoha, Qatar

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Risk Management - Critical Points

Handling of room temperature products during stopover

TarmacDoha Qatar

Pallets of tablet blistersF kf tFrankfurt to Saudi ArabiaT°> +70°CFlight

WH airportJeddah

Tarmac

WH airport

TransportConsigneeWHFlight WH

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Risk Management - Critical Points

Airfreight Pallet

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Risk Management - Critical Points

Deviation InvestigationBlister after manufacture Blister after 30 min. at +70°C

Probable cause: direct sunlight on plastic wrapped pallet on tarmacg p pp p

Immediate solution: direct flight Frankfurt to Jeddah

Future: better handling on tarmac / use of reflecting metallic plastic foil

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Risk Management

Quality Management System Ref: IATA PCR 17.12

Approved written procedures and specifications

Individuals’ roles and responsibilities

Corrective and preventive action (CAPA) programCorrective and preventive action (CAPA) program

Documented training program

Applicable calibration programsApplicable calibration programs

Quality metrics

Audit program

Deviation management system

Change control procedures

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Management controls

Risk Management - QMS

Training

Personnel must be qualified, based on their education, training and/or experience, to perform their assigned functions.

Initial and periodic training is required and should be documented to ensure personnel are proficient in their specific job functions and responsibilities.p j p

Training should address the policies, processes, procedures, and written instructions related to operational activities the product/service and the quality systemactivities, the product/service and the quality system.

Ref: IATA PCR 17 12 5 Personnel

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Ref: IATA PCR 17.12.5 Personnel

Distribution of Pharmaceutical Products

It is more than just storage d t tand transport

It is part of product quality assurance

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Key Expectations of the Transportation Supplier

Thank you for your attention

Any questions?

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