SAP ERP AND CLINICAL TRIAL SUPPLIES

Laura Bonino

CTS Coordinator, Chiesi Farmaceutici SpA

Laura Bonino, Cannes, 25-26 Feb 2015

OUTLINE

Chiesi Presentation

The CTS management in Chiesi

The ERP SAP

Chiesi’s requirements for SAP implementation in CTS management

CTS management with SAP

Next steps?

Questions

2

Chiesi Group: Fact & Figures 2013

3

Founded in 1935/ Privately owned:

Employees : 3.885; 1.560 in Italy

Revenues : 1.237 M €

R&D Investments: 168 M €

Direct presence: 25 countries

• Respiratory diseases

• Neonatology & Special Care Diseases

• Cardiovascular

• Rare diseases

Key Facts Therapeutic Focus

0

300

600

900

1200

1500

2008 2009 2010 2011 2012 2013

Export

Affiliates

Italy

749 872

1,015

Consolidated Sales (millions €)

1,057 1,107

Headcount 3,243 3,534 3,737 3,814 3,830 3,885

1,237

Chiesi Group: Fact & Figures 2013

4

The Strategic View

5

Chiesi Group – Sales by Therapeutic Area 2013

6

Research & Development: Facts & Figures 2013

7

Research & Development

8

Research Centre: Parma, IT

9

Research & Development: Pipeline

10

Respiratory

Neonatology

Other, Special Care

R&D Pipeline

OUTLINE

Chiesi Presentation

The CTS management in Chiesi

The ERP SAP

Chiesi’s requirements for SAP implementation in CTS management

CTS management with SAP

Next steps?

Questions

11

CTS MANAGEMENT IN CHIESI

CTS MANAGEMENT

CLINICAL OPERATIONS

CMC (Chemistry

Manufacturing & Controls)

GMP DP PRODUCTION

UNIT

GMP

CTS UNIT

QC

WAREHOUSE MANAGEMENT

QUALITY ASSURANCE/

QUALIFIED PERSON

12

CTS MANAGEMENT IN CHIESI – CLINICAL OPERATIONS

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CLINICAL OPERATIONS

Preparation of the CTS request

form;

Shipment of the CTS from the

warehouse to the clinical sites or

the central depot.

CTS MANAGEMENT IN CHIESI – CMC

Planning and production of the batches to be used in the clinical trial (active and placebo)

14

CMC (Chemistry

Manufacturing & Controls)

GMP DP PRODUCTION

UNIT

GMP

CTS UNIT

QC

Planning and forecasting of CTS required for

clinical trial

Planning and production of comparator

matched placebos;

Blinding of the selected comparators;

Packaging & Labelling of CTS

Analysis and release of the batches for the clinical trials, included the manipulated comparators and placebo;

Performing in process controls during the packaging and labelling activities.

CTS MANAGEMENT IN CHIESI – QA/QP

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Evalutation of the batch records

of the drug product.

Evaluation of the packaging

batch records.

GMP & QP release of the final

product.

QUALITY ASSURANCE/

QUALIFIED PERSON

CTS MANAGEMENT IN CHIESI – WAREHOUSE

16

WAREHOUSE MANAGEMENT

Storage of the drug product and

of the CTS

Preparation of the shipment from

the warehouse to the clinical

sites or to the central depot.

OUTLINE

Chiesi Presentation

The CTS management in Chiesi

The ERP SAP

Chiesi’s requirements for SAP implementation in CTS management

CTS management with SAP

Next steps?

Questions

17

THE ERP SAP

ERP = Enterprise Resource Planning

Objectives:

• Integration: a unique integrated system, that contains all the

information and the requirements for the whole Chiesi group.

• Standardization: standardization and simplification of the

processes (administrative, productive, supply chain,

procurement…).

• Simplification: simplified corporate structure, market channel,

and business scenario management.

18

From JDE to SAP: 5 phases

1. Project Preparation: project landscaping & detailed project

planning

2. Business Blues Print: confirm business requirements and

identify/integrate new detailed ones, finalize project

landscaping, analysis of the organizational impact

3. Realization: Development and test of the solution identified

in the previous phase, system validation

4. Final preparation: end user training, data migration &

system production environment preparation

5. Go Live & Support

19

SAP: Selected modules for CTS management

BC Basic Component

FI Financial Accounting

FI-CA

AM Asset Management

CO Controlling

CS Customer Service

MM Materials Management

WM Warehouse Management

SD Sales and Distribution

LE Logistic Execution

PP Production Planning

PS Project System

PM Plant Maintenance

QM Quality Management

HR Human Resources 20

CTS MANAGEMENT IN CHIESI: SAP

CTS MANAGEMENT

CLINICAL OPERATIONS

CMC (Chemistry

Manufacturing & Controls)

GMP DP PRODUCTION

UNIT

GMP

CTS UNIT

QC (*)

WAREHOUSE MANAGEMENT

QUALITY ASSURANCE

21

(*) With LIMS

OUTLINE

Chiesi Presentation

The CTS management in Chiesi

The ERP SAP

Chiesi’s requirements for SAP implementation in CTS management

CTS management with SAP

Next steps?

Questions

22

CHIESI’S REQUIREMENTS FOR CTS MANAGEMENT

FULL TRACEABILITY AT KIT LEVEL;

VALIDATED SYSTEM;

MANAGEMENT OF IN HOUSE AND OUTSOURCED ACTIVITIES

23

OUTLINE

Chiesi Presentation

The CTS management in Chiesi

The ERP SAP

Chiesi’s requirements for SAP implementation in CTS management

CTS management with SAP

Next steps?

Questions

24

CTS MANAGEMENT WITH SAP – IN HOUSE

All the in house GMP activities (manufacturing, primary

and secondary packaging) are managed through a ODP

(ordine di produzione = production order);

Before starting the manufacturing, the production

planner issues the ODP.

Before starting the primary and secondary packaging,

the CTS coordinator issues the ODP in SAP.

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CTS MANAGEMENT WITH SAP – MASTER DATA

EACH MATERIAL WAS IDENTIFIED WITH A NUMBER;

THIS NUMBER CONTAINS AN IDENTIFIER OF THE TYPE OF

MATERIAL (PACKAGING, DRUG PRODUCT, CLINICAL STUDY,

API…);

THIS NUMBER IS LINKED TO A DATABASE THAT MANAGE ALL

THE CARATHERISTICS OF THE MATERIAL: RECHECK PERIOD,

QUALITY STATUS, PRODUCTION PLANT, STORAGE

TEMPERATURE…

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CTS MANAGEMENT WITH SAP – MATERIALS

EACH CLINICAL TRIAL IS IDENTIFIED WITH A CODE NUMBER IN SAP.

A SPECIFIC MATERIAL TYPE WAS CREATED FOR CLINICAL TRIAL MATERIAL.

EACH KIT TYPE AND EACH PACKAGING CAMPAIGN ARE IDENTIFIED BY THE BATCH NUMBER.

FOR EXAMPLE:

• THE CLINICAL STUDY CCD-XXXX-NNN IS IDENTIFIED BY CODE 0900000001;

• THE TREATMENT KITS OF THE FIRST CAMPAIGN ARE IDENTIFIED BY CODE 0900000001 BACTH N. 1002736;

• THE TRAINING KITS OF THE FIRST CAMPAIGN ARE IDENTIFIED BY CODE 0900000001 BACTH N. 1002737;

• EACH BATCH NUMBER IDENTIFIES A DIFFERENT ODP:

− 1 ODP = 1 BATCH NUMBER = 1 KIT TYPE OF 1 CAMPAIGN.

• MATERIAL CODE + BATCH NUMBER ARE UNIQUE IN CHIESI SYSTEM.

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CTS MANAGEMENT WITH SAP - BATCH NUMBER

The batch numbers are assigned by the system and they guarantee

the traceability of the material; two different approach to batch

numbering are available:

• AUTOMATIC BATCH NUMBERS: In case of blinded kits or open label

kits that include more than one product, the batch number of the

packaging lot is the ODP number.

• MANUAL BATCH NUMBERS: in case of open label kits, containing only

one product, the packaging batch number is the same of the product

batch number.

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CTS MANAGEMENT WITH SAP – ODP

THE PRODUCTION ORDER MANAGES:

• INPUT MATERIALS (IDENTIFICATION, BATCH NUMBERS, REQUIRED

QUANTITY);

• SITE AND SECTION OF PRODUCTION;

• FINAL MATERIAL (IDENTIFICATION, BATCH NUMBER, REQUIRED

QUANTITY, EXPIRY/RECHECK DATE AND STORAGE CONDITIONS);

• LABELS TO BE ATTACHED TO THE EXTERNAL PACK.

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17 Feb 2015 31/12/2016

CTS MANAGEMENT WITH SAP – ODP

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Used by operators to

link the input material

to the operation

Ready for production

Input material: through a transfer order generated by

the ODP, the warehouse personnel bring the required

material to the production room. The operators must

associate the labels on each input material with the

ODP through a barcode.

16 Feb 2015

17 Feb 2015 LBonino

Packer 100 Notes

16 Feb 2015

120 110

210

17 Feb 2015 31/12/2016

CTS MANAGEMENT WITH SAP – ODP AFTER PRODUCTION

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Management through

radio-frequency

Management through

radio-frequency

Management through

radio-frequency

CTS MANAGEMENT WITH SAP - RADIOFREQUENCY

HANDLING UNIT (HU): Each pallet and container in SAP is identified as

handling unit and has a barcode that contains the main information about

the container (material, batch n, quality status) and that allows the

movement of the HU;

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RADIOFREQUENCY (RF):

Machine able to read the barcode

and to manage the movement of

the HUs.

CTS MANAGEMENT IN SAP: RADIOFREQUENCY

Movement of the material through the warehouse, from

the warehouse to the production areas and from the

production areas back to the warehouse.

Association of the input materials to the odp, in order to

check the identity and the quantity.

Reconciliation of the used materials: used, rejected and

returned material.

Loading of the final cts in the warehouse.

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CTS MANAGEMENT IN SAP: LABELS

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CHIESI FARMACEUTICI – PARMA (ITALY)

Cod .: NNNNNNNNNN Lot .: XXXXXX

CTS Europe Study

FOR CLINICAL TRIAL USE ONLY

Im b./ Box Nr .

0 0 01 / 00 10

SIGLA/ DATA: .…………….

STORAGE CONDITIONS: +2 + 8°C

TREATMENT FROM 001 TO 100

Management through

radio-frequency

Information retrieved from

the ODP

CTS MANAGEMENT IN SAP: STOCK

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SAP MANAGES THE

STOCK OF EACH

PRODUCT;

AT THE END OF THE

PRODUCTION, THE

KITS ARE IN CHIESI’S

WAREHOUSE, AS A

TOTAL QUANTITY.

CTS MANAGEMENT IN SAP: SUB-BATCHES

IN ORDER TO TRACK EACH KIT, THE RANDOMIZATION LIST IS

IMPORTED IN SAP AND THE TOTAL QUANTITY OF KITS IS

DIVIDED IN SUB-BATCHES: EACH SUB-BATCH IDENTIFIES A

KIT.

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List of sub-batches: they

guarantee the tracking of

each kit: where is stored,

where & when it is shipped to

the clinical site.

CTS MANAGEMENT IN SAP: USE OF IRT

In case of IRT use, the partition in sub-batches is not needed

because the IRT track the shipments of each kit.

The entire batch of packaged material is shipped to the central

depot and the traceability is guaranteed by the IRT.

As soon as this shipment is performed, the CTS are no more visible

in SAP, because they can be managed through the IRT.

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SAP: A CONNECTION BETWEEN DIFFERENT DEPARTMENTS AND ACTIVITIES

38

GMP DP PRODUCTION

UNIT

GMP

CTS UNIT

QC

WAREHOUSE MANAGEMENT

QUALITY ASSURANCE

CLINICAL SITE/DEPOT

EFFECT OF SAP ON OUR CTS SUPPLY CHAIN

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SHORT TERM EFFECTS

EFFECT OF SAP ON OUR CTS SUPPLY CHAIN

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EFFICIENCY

CONTROLLED

PROCESSES

INTEGRATION

BETWEEN

DIFFERENT

DPT.