A New Shipping Strategy - FlyPharma · 2017. 6. 13. · MSD A New Shipping Strategy Introducing a...

MSD A New Shipping Strategy Introducing a new model for pharma handling services

Ruud van der Geer FlyPharma Conference Brussels, 07 June 2017

2

Agenda topics

Intro MSD Product Handling Robustness • Step 1: Compliance • Step 2: Product & Process Control Limits Case Study

• Step 2: Product & Process Control Limits, forward looking thoughts and vision • Step 3 + 4: Thermal Protection Solutions (TPS) and Monitoring • Step 5: Performance Monitoring

Take Home & Implement

About MSD

We are a global healthcare company with a 126-year history of working to make a difference in global health.

HEADQUARTERS Kenilworth, NJ, U.S.A. operating in more than

60 countries

Merck & Co., Inc. is our legal name and is listed on the New

York Stock Exchange under the symbol "MRK."

EMPLOYEES approximately 69,000

worldwide (as of 31MAR17)

2016 REVENUES $39.8 billion; 54% of sales come from outside the United States

2016 R&D EXPENSE $6.8 billion; 19 drug candidates in late-stage development

BUSINESSES Pharmaceuticals, Vaccines, Biologics and Animal Health

HELPING THE WORLD BE WELL

1. COMPLIANCE

PRODUCT STABILITY

PROTECTION

MONITORING

KPI TRACKING

2.

3.

4.

5.

Define Control Limits

Define Control Measures

Ensure Process Visibility

Monitor Performance

“True North”

MSD requirements and expectations for robust temperature controlled

logistics

4

Robust Temperature Controlled Logistics for Manufacturing Companies A NEW Shipping Strategy

Product Handling Pyramid WHY?

WHAT?

HOW?

COMMUNICATION

Product Handling Pyramid




Monitor Performance

5

Control Limits

NEW STRATEGY

A NEW Shipping Strategy

As an opportunity to improve our compliance posture

CONTROL & CONTINUOUS IMPROVE

E2E VISIBILITY

Define Shipping Control Limits “What to Control?”

Product & Process Control limits A NEW Shipping Strategy

LONG TERM

STATIC TEMP

CONTROL- ABLE

STORAGE

SHIPPING

VARIABLE TEMP

UNCONTROL- ABLE

ELEMENTS

SHORT TERM

7

xx%

xx%

xx%

xx%

xx%

Case Study

Percentage of extreme minimum and maximum temperature in range

NEW PROCESS CAPABILITY

MIN & MAX Recorded

Temperatures

0

2

40

15

30

25

LCL UCL

15

0

30

30


Lane Capability

How to define Lane Capability and, “what does Good look like?” 1

What does GOOD look

Like?

Labeled Storage Req.

Allocated Stability Data

Shipping Range

Case Study A NEW Shipping Strategy

NEW PROCESS CAPABILITY All Shipments

NEW PROCESS CAPABILIT Y

Lane Capability

Current State

X Ѵ EXAMPLE of an EU Labeled Room Temperature Product

“Store below +30C”

T (ºC)

# Shipments

Future State Lane Improvement Program 1 2

9

Forward looking thoughts and vision


Next Steps A NEW Shipping Strategy

Approved Strategy

Need for industry wide collaboration

SHIPPING BY PROCESS CAPABILITY NEW

COMMUNICATION CONTROL & CI E2E VISIBILITY

CAN WE PROTECT?

CAN YOU DELIVER?

10



CONTROL

Need for air cargo industry wide STANDARD RANGES


Linking to the IATA Special Handling Codes

PIL (Pharmaceuticals)

+

SPECIAL HANDLING CODE Low Temp High Temp

DNF 0 DO NOT BOIL?

ERT +2 +25

CRT +15 +25

COL +2 +8

FRO ... -10C

CAN YOU DELIVER?

11



CONTINUOUS IMPROVEMENT

Need for air cargo industry wide PROGRAMS


Linking to the IATA CEIV & Pharma.Aero programs o To prove Process Control by adapting GDP Reg. Expectations o To prove Process Capability

“HOW TO MAKE THIS TANGABLE?”

12



COMMUNICATION

Need for air cargo industry wide STANDARD COMMUNICATION


+15°C to +25°C

19 May 2016 / 11:05

STANDARD AWB TEXT

+15°C to +25°C +2°C to +25°C DO NOT FREEZE

+2°C to +8°C

COLD CHAIN

NEW 0°C to 40°C?

CRT PRODUCTS

Passive Packouts

1. COMPLIANCE

PRODUCT STABILITY

PROTECTION

MONITORING

KPI TRACKING

2.

3.

4.

5.




Monitor Performance

“True North”


logistics

13



14

Standard Thermal Protection Systems & Monitoring A NEW Shipping Strategy

NEW SHIPPING RANGES IDENTIFIED

“The Menu”

Target Shipping Range

LCL UCL

Update NOW

DEFINED

15

Standard Thermal Protection Systems & Monitoring A NEW Shipping Strategy

Shipper always to use a QUALIFIED

thermal protection system

EXAMPLE

“The Menu”

Target Shipping Range Monitor

Thermal Protection System (TPS)

Large/Medium/Small

(L/M/S) LCL UCL ID

PASSIVE

(HIGH END) PASSIVE

ACTIVE / HIGH END PASSIVE

Standard Thermal Protection Systems & Monitoring

16


EXAMPLE

Target Shipping

Range Monitor Thermal Protection

System (TPS)

Large/Medium/Small (L/M/S)

Transportation Service

Flights (In)direct / Routes

INTERNAL KPI (FPQ%)

Current State

Future Target LCL UCL ID

PASSIVE

(HIGH END) PASSIVE


EXAMPLE

“The Menu”

Adding Transportation related Control Levers and

agreed performance measures

Update BEING

EXPLORED

Standard Thermal Protection Systems & Monitoring

17


EXAMPLE

Target Shipping

Range Monitor Thermal Protection

System (TPS)

Large/Medium/Small (L/M/S)

Transportation Service

Flights (In)direct / Routes

INTERNAL KPI (FPQ%)

Current State

Future Target LCL UCL ID

PASSIVE

(HIGH END) PASSIVE


EXAMPLE

“The Menu”

Lane A

Lane C

Lane D

Depending on requirements

and capabilities (based on Lane

Risk Assessment)

Lane B

1.

2.

3.

4.

5.




Monitor Performance

“True North”


logistics

18



Dashboards

Performance Monitoring A NEW Shipping Strategy

Trending & Continuous Improvement

EXAMPLE

• There is a difference between Storage Conditions and Storage Requirements! • “Transportation as an extension of Storage” should be a Target Condition but

is currently not 100% achievable and realistic globally • With a proper Risk Assessment Program and Supporting Product Stability

Data it can be demonstrated that short term deviations from labeled storage conditions have no impact on product quality and investigations can be limited

• Standard Temperature Ranges & Communication to be defined and accepted Industry wide!

• Standard Improvement Programs need to be defined and Industry wide accepted!

• These can be used to support Collaborative Continuous Improvement of the shipment process and provided services

Take Home & Implement A NEW Shipping Strategy

21

Ruud van der Geer MSD Supply Chain Management Center of Excellence EMEA Product Handling [email protected] +31 23 515 3101

mailto:[email protected]

MSD �A New Shipping Strategy�Introducing a new model for pharma handling servicesSlide Number 2Slide Number 3Robust Temperature Controlled Logistics for Manufacturing Companies Control LimitsProduct & Process Control limitsCase StudyCase StudyNext StepsProduct & Process Control limitsProduct & Process Control limitsProduct & Process Control limitsRobust Temperature Controlled Logistics for Manufacturing Companies Slide Number 14Slide Number 15Slide Number 16Slide Number 17Robust Temperature Controlled Logistics for Manufacturing Companies Performance MonitoringTake Home & ImplementSlide Number 21

A New Shipping Strategy - FlyPharma · 2017. 6. 13. · MSD A New Shipping Strategy Introducing a...

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