Good Supply Practices

Supply by Design for the 21st Century

Xavier Health Mission

www.XavierHealth.org

• FDA/Xavier PharmaLink Conference • FDA/Xavier MedCon Conference • Xavier AI Summit • Xavier Combination Products Summit

Leading Innovation

CONFERENCES

INITIATIVES

DEVELOPMENT • Medical Device Leaders Certificate Program • Cultural Quantitation and Transformation • EU MDR Workshop • Good Supply Practices Workshops and Training

• Xavier Artificial Intelligence Initiatives • Chief Quality Officers Forum • Xavier Supply by Design Initiative • Amerisource Bergen Serialization Pilot Study • Development of a Bachelor of Quality Science

Over 150 FDA officials and industry professionals engaged on our teams

GMP GSP

GIP GDP

Increase Product Confidence

With the End in Mind

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5 countries

39 companies

2 industries + FDA

4 New Key Concepts

1 Major Paradigm Shift

11 Practical Solution Tools

Problem Statement

We are unable to reliably and consistently ensure the supply of incoming materials used in

products to serve the Pharmaceutical and Medical Device industries

Therefore, we need greater assurance that suppliers can reliably and consistently supply safe

and quality materials/products to limit adverse impact on end-user safety and brand equity

Gap Analysis – Points to Ourselves

1. Product and Process Knowledge. We lack understanding of our own product and process to know what we truly need from our suppliers.

2. Supply Chain Development. We circumvent our own systems when developing our supply chain, and do not engage our suppliers as subject matter experts.

3. Supply Chain Management. We do not behave as trusted partners in our supplier relationships, and do not respect the business of our suppliers.

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Paradigm Shift

• August 2012: we wanted to focus on certifying our suppliers

• July 2013: top data is pointing to ourselves as the root cause

August

2012

July

2013

We are

Causing

Problems

Our Suppliers

Are Causing

Problems

Action Provoking! 8

% of time willing to share process capability data and/or composition of material with customers

9% 5%

8%

12%

56%

10%

<10

10-25

26-50

51-75

>75

Not Sure

Data from Suppliers

% of customers who ask to see your process capability data and/or composition of material information

17%

17%

15% 11%

29%

11%

<10

10-25

26-50

51-75

>75

Not Sure

Data from Suppliers

% of time it is critical to know the intended-use of your product/material

9% 7%

7%

11%

58%

8%

<10

10-25

26-50

51-75

>75

Not Sure

Data from Suppliers

% of customers who share their intended-use of your product/material

4% 7%

13%

18% 52%

6%

<10

10-25

26-50

51-75

>75

Not Sure

Data from Suppliers

% of customers ask for your input on specifications for your product/material

8% 15%

17%

23%

29%

8%

<10

10-25

26-50

51-75

>75

Not Sure

Data from Suppliers

4 New Concepts

1. Supply by Design

2. Cross-Functional Alignment

3. Self-Qualification

4. Relationship Risk Mapping

Key Differentiator!

GSP Value

Quality by

Design

Supply by

Design

Product in Development

Product on Market

Integrated Risk

Reduction

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Cross-Functional Alignment

Who do you Involve Today?

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Cross-Functional Alignment Functional

Area Examples of

what is needed from the supplier by the functional

area

Examples of what can be contributed to the

supplier selection process by the functional area

Does the functional group feel their involvement has

been missed, or not at the right time?

Score likelihood of involving each cross-functional member going

forward

EH&S Supplier’s capabilities

Supplier’s compliance

Impact of material and supplier

Supplier’s Risk Profile

Carbon footprint

Safety Data Sheets

Identify regulatory requirements

Assurance of Supplier’s compliance

Audit supplier Supplier/material

impact on Company, e.g., Waste disposal, hazards, Risk class

Environmental impact

Historical experience with suppliers

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Communication Strategy

What information are companies concerned

about sharing?

Why would the suppliers need to know this

information?

What is the risk of sharing this

information?

What is the benefit of sharing this

information?

Actual flexibility in shipping/production schedules

To understand demands and work collaboratively to meet needs

Supplier may take greater risk. Supplier may delay manufacturing if extra time is allowed

Improve availability of supply from synergies of treating supply chain as a single system. Supplier may be able to adjust their schedule

Function of supplier's product in formulation/device

To assist in choosing correct product to supply for given function

IP concerns May raise cost

Get the best product for the application

Cost/profit margin

To come to an agreement on price that is fair for supplier and manufacturer

Supplier may increase their price

Long term benefit of relationship building. Assists supplier with improving efficiencies 19

If We Are Causing, or Could Have Prevented All of Our Supply Chain

Failures, then….

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How Qualified are We to be in Our Own Supply Chain???

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Self-Qualification Example

Section 4: Product and Process Technical Capability Score

1 Our process control ranges and product specification ranges are supported by data and/or have scientifically sound justification.

2 Our technical transfer for process and/or analytical/test methods meet predetermined protocol requirements first time.

3 We understand the process capability of our key suppliers for their manufacturing process, and have action limits around that process capability.

4 We discuss with our Key Suppliers the appropriate specifications to have in place for their material, and have documentation to demonstrate the suppliers’ agreement with those specifications.

Category Examples of Criteria to Assess Relative

Importance?

Does Supplier fit your need?

Supplier

Product &

Process

Technical

Capability

Possesses specific technical expertise, process

capabilities and experience

Suppliers have demonstrated process

improvements to afford future economies of

scale to support price negotiation

opportunities for ongoing win-win

Packaging type meets the business needs

(amount of material needed, type of package

needed)

Ability to handle hazardous material

We have familiarity with the equipment used

by the supplier

Supplier Requirement Alignment

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Relationship Risk Mapping

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0

10

20

30

40

50

60

70

80

Supplier 1 Score

Supplier 2 Score

Self Score

Operating Systems and Business Capability

Relationship Alignment

Quality and Regulatory Compliance

Product and Process

Technical Capability

Pulling it All Together

Supply by Design for the 21st Century

Good Supply Practices

1. Setting the Foundation a. Cross-Functional Team Formation

b. Self-Qualification

c. Knowledge Management (and supply chain intelligence repository)

d. Supply Chain Risk Management Triage

2. Internal Alignment a. Internal Alignment on Material

Requirements

b. Internal Alignment on Supplier Requirements • Single Source vs. Multi-Source

c. Communication Strategy

3. External Alignment a. Supplier Engagement

b. Holistic Supplier Qualification

c. Relationship Risk Mapping

4. Lifecycle Management

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= Solution Toolkit

“Where do I Start?”

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Risk Management Triage

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Step 1:

Product-Related Risk

Impact of Product-Related Risk

(Low Impact = 0, Slight Impact = 3,

Moderate Impact = 7, High Impact = 10)

Manufacturing Complexity

Pharma: biologic, vaccine, sterile,

nonsterile, etc.

Device: Class III, Class II, Class I, etc.

Score based on the impact of the amount

of risk due to the complexity of the

manufacturing process

Product Sensitivity

Sterility, temperature sensitivity, light

sensitivity, etc.

Score based on the difficulty in maintaining

and assuring conditions to protect product

sensitivity.

Stock-out risk to patients

New product, orphan product, etc.

Score based on the impact that a stock-out

would have to patients.

Financial risk to the business

High cost of discards, loss of market

share, impact to shareholders, etc.

Score based on the financial impact that

risks would have to the business.

Overall Impact Score: Minimum = 0; Maximum = 40

Product Risk Determination

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Risk Management Triage

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Step 2:

Material-Related Risk Impact of Material-Related Risk

(Score 0, 3, 7, or 10)

Used in patient and/or business critical

products

No = 0; Yes = 10. Based on product

assessment.

Degree of use across product lines Score as low impact if the material is isolated to

few products

Available inventory (internally and/or

externally). Consider supplier’s reject/discard

rate

Score low if internal inventory is acceptable to

meet market demand and/or if inventory is

easily sustained (multi-sourced, etc.)

Criticality of the material to the finished

product. Consider impact of process capability

variability

Score low if the material does not play a critical

functional role in the finished product.

Material performance based on information in

the supply chain intelligence repository

Score low if historical performance is

acceptable

Financial impact - Cost of material and/or

service, cost and time of alternate source

Score low if financial impact is low

Overall Impact Score: Minimum = 0; Maximum = 60

Material Risk Determination

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Risk Management Triage

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Step 3:

Assess the Supplier’s performance against the outcome of the “Internal Alignment on Supplier Requirements” Tool

Risk Management Triage

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Step 4:

High Volume Supplier

– The Supplier supplies many materials to your company

– No single material is what you would consider high volume

– No single material cuts across numerous product lines

– However, if a significant issue occurs with this Supplier (e.g., compliance, financial stability, facility issue, etc.), then many of your products are impacted

Example of Automatic Risk Elevation

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1. Map your supply chain

2. Conduct a risk assessment

3. Start using the GSPs in a way that makes sense for your business and is commensurate with the need

Perhaps Start by: – Using the Cross-Functional Alignment tool to establish a cross-functional

team to operate within your current systems

– Using the Internal Alignment on Supplier Requirements Tool next time you need to make a change to a supplier or have a new product

– Developing a Communication Strategy

– Conducting the Self-Qualification

So, Where Can You Start?

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Good Supply Practices

1. Setting the Foundation a. Cross-Functional Team Formation

b. Self-Qualification

c. Knowledge Management (and supply chain intelligence repository)

d. Supply Chain Risk Management Triage

2. Internal Alignment a. Internal Alignment on Material

Requirements

b. Internal Alignment on Supplier Requirements • Single Source vs. Multi-Source

c. Communication Strategy

3. External Alignment a. Supplier Engagement

b. Holistic Supplier Qualification

c. Relationship Risk Mapping

4. Lifecycle Management

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• British Standards Institution (BSI) – Currently establishing a Steering Group to convert the GSPs into a Publicly

Available Standard (PAS)

• United States Pharmacopeia (USP) – Currently establishing an Expert Working Group to convert the GSPs into a

General Chapter above 1000

• APEC Supply Chain Security Toolkit – Possible to add as a tool in the Supply Chain Security Toolkit once change

management is established

• Global Training – Company Specific, Live Virtual, and Workshops – Through Pathway for Patient Health and BSI

GSP on a Global Platform

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Good Supply Practices

• Supply by Design

• for the 21st Century

Thank you!!

Marla A. Phillips phillipsm4@Xavier.edu

513-745-3073