Adopting JIT labeling for clinical studies Dr. Julia Kaestel

Senior Clinical Supplies Project Manager

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 2

1. Issues and challenges in planning study specific clinical supplies

2. How to apply JIT labeling and packaging - First steps and strategies

3. JIT process at AbbVie Global Drug Supply Management

4. What comes next?

Agenda

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 3

• Lead times

• Bulk Material

• Comparator costs

• Booklet labels costs

• Country list

Issues and Challenges – Planning Study specific Clinical Supplies

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 4

• Pooled supplies Strategy

Packaging and labeling of material for several studies sharing the same design

• Pre-packaging Strategy

Prebottling of tablets or capsules, no labeling activities included

How to apply JIT labeling and packaging- First steps and strategies

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 5

Just In Time Labeling – conventional Packaging vs. JIT

Study-Specific Secondary Packaging & Labeling

(single panel or booklet with variable)

Primary Packaging (not study-specific)

Consignment

Shipment

Consignment

Primary Packaging (not study-specific)

Study-Specific Secondary Packaging & Labeling (country-specific single panel)

Shipment

Conventional Packaging JIT

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 6

JIT Process in Detail

Plan : development plan, funding, request bulk and order commodities

Prep : countries, label designs, shipping document templates, packaging documentation preparation / templates

Execute : consignment requests, print labels, pack & label, ship; specified turn-around time

Plan

Prepare for On Demand Packaging,

Labeling and Shipping at a Study Level

On Demand Packaging,

Labeling and Shipping

Prep Execute

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 7

JIT Process in Detail

Prep Execute

Packaging and Documentation Preparation

Consignment specific Packaging Documentation

Packaging of request Lot

Pharmacy Op.

Create Batch Record

Release of packaged Material

QA

Release

Performs consignment

specific labeling and

documents in Master Batch

Record

Pharmacy Op. / MM

Completed Master Batch

Record

Releases (Batch-

Record & KiTs)

QA

Release

requests

Study Manager

Order

Study Manager

Consignment (country and site specific)

Order

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 8

JIT Process in Detail

Pharmacy Op.

Create Batch Record

QA

Release

Pharmacy Op. / MM

Completed Master Batch

Record

QA

Release

Study Manager

Order

Study Manager

Order

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 9

JIT Process in Detail

• Label Design Request

• Packaging Request of new lot

• Not country specific

• Master Label Design

• Packaging of new lot, no label added

• Preparation of documentation

Pharmacy Op.

Create Batch Record

QA

Release

Pharmacy Op. / MM

Completed Master Batch

Record

QA

Release

Study Manager

Order

Study Manager

Order

• Release of packaged material (none country specific)

Consignment request: 4 Bottles Lot active 8 Bottles Lot placebo site X country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform Labeling of KITs

3.Assemble shipment corrugates for site X, country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform Labeling of KITs

3.Assemble shipment corrugates for site X, country X

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 10

JIT Process in Detail

Pharmacy Op.

Create Batch Record

QA

Release

Pharmacy Op. / MM

Completed Master Batch

Record

QA

Release

Study Manager

Order

Study Manager

Order

• Label Design Request

• Packaging Request of new lot

• Not country specific

• Master Label Design

• Packaging of new lot, no label added

• Preparation of documentation

• Release of packaged material (none country specific)

Consignment request: 4 Bottles Lot active 8 Bottles Lot placebo site X country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform Labeling of KITs

3.Assemble shipment corrugates for site X, country X

Consignment request: 4 Bottles Lot active 8 Bottles Lot placebo site X country X

Consignment request: 4 Bottles Lot active 8 Bottles Lot placebo site X country X

Consignment request: 4 Bottles Lot active 8 Bottles Lot placebo site X country X

Consignment request: 4 Bottles Lot active 8 Bottles Lot placebo site X country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform Labeling of KITs

3.Assemble shipment corrugates for site X, country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform Labeling of KITs

3.Assemble shipment corrugates for site X, country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform Labeling of KITs

3.Assemble shipment corrugates for site X, country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform Labeling of KITs

3.Assemble shipment corrugates for site X, country X

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 11

Pro

• More flexibility, e.g. additional countries

• Reduced label design and approval time lines

• Reduced booklet costs

• Reduced waste

Cons

• One Batch record per consignment

JIT – Pros & Cons

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What comes next?

Prep Execute

Packaging Documentation Preparation

Consignment specific Packaging Documentation

Pharmacy Op. System Pharmacy Op. /

MM QA Study Manager

Prep Execute

Packaging and Documentation Preparation

Consignment specific Packaging Documentation

Pharmacy Op. QA Pharmacy Op.

/ MM QA

Study Manager

Study Manager

Current Process:

NEW Process:

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JIT – Outlook

Prep Execute

Packaging Documentation Preparation

Consignment specific Packaging Documentation

Prepares Batch Documentation,

Creates a template to be used for each consignment

Pharmacy Op.

Create Template

Adds consignment

specific information to template

System

Create Instructions

Performs packaging and documents in Batch Record

based on instructions

Pharmacy Op. / MM

Completed Batch Record

Releases (Batch-

Record & KITs

QA

Released BR

requests (preparation for)

packaging of a new packaged

lot

Study Manager

Order

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 14

JIT – Outlook

Study Manager Pharmacy Op.

Order Create Template

System

Create Instructions

Pharmacy Op. / MM

Completed BatchRecord

QA

Released BR

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1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active, 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform P&L of KITs

3.Assemble shipment corrugates for site X, country X

JIT – Outlook

Order Create Template Create

Instructions Completed

BatchRecord Released

BR

Study Manager Pharmacy Op. System Pharmacy Op. /

MM QA

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active, 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform P&L of KITs

3.Assemble shipment corrugates for site X, country X

1. Pick List: labels, packaging material

2. Perform Packaging & Labeling of KITs

Program Study Labels Lot Number Kit Number Countries

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active, 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform P&L of KITs

3.Assemble shipment corrugates for site X, country X

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 16

JIT – Outlook

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active, 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform P&L of KITs

3.Assemble shipment corrugates for site X, country X

Order Create Template Create

Instructions Completed

BatchRecord Released

BR

Study Manager Pharmacy Op. System Pharmacy Op. /

MM QA

1. Pick List: labels, packaging material

2. Perform Packaging & Labeling of KITs

Program Study Labels Lot Number Kit Number Countries

IVRS

For Study X, ship KITs 5555, 6731, 1111 to Site A, Country, …

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active, 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform P&L of KITs

3.Assemble shipment corrugates for site X, country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active, 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform P&L of KITs

3.Assemble shipment corrugates for site X, country X

1.Pick List: e.g. 4 Bottles Lot active 8 Bottles Lot placebo 4 Bottle labels active, 8 Bottle labels placebo 2 box labels active, 4 box labels placebo 6 boxes

2.Perform P&L of KITs

3.Assemble shipment corrugates for site X, country X

For Study X, ship KITs 5555, 6731, 1111 to Site A, Country, … For Study X, ship KITs 5555, 6731, 1111

to Site A, Country, … For Study X, ship KITs 5555, 6731, 1111 to Site A, Country, … For Study X, ship KITs 5555, 6731, 1111

to Site A, Country, … For Study X, ship KITs 5555, 6731, 1111 to Site A, Country, … For Study X, ship KITs 5555, 6731, 1111

to Site A, Country, …

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 17

• Current JIT process: Reduces costs

Saves time

Saves bulk material

Makes more flexible

Reduced waste

• New process compared to the current JIT process: Less release steps by QA

Less manual steps

Summary

Adopting JIT labeling for clinical studies | February 2015 | Company Confidential © 2015 18

Thanks a lot for your Attention!