School Serialization for Pharma CMO/CPO’s

Back to

How to survive and thrive in the era of serialization

Anything new?

Agenda

Introduction

Today

Challenges

Solutions

Next Steps

PharmTech Inc.

Serving FDA regulated industries since 1995 Involved in Track & Trace since 2005. Working with a Top 10 Pharma Co. and Virtual Manufacturer Industry speaker at conferences, webinars and author of white papers on e-Pedigree/ serialization in pharmaceuticals. Diversified Team Skills; • IT Integration • Quality Management • Distribution • Serialization • Line Integration (Packaging & Manufacturing) • GS1 Standards

PharmTech Project List

• Evaluating solutions providers

• Implementing GS1 Standards

• Piloting for serialized product and trades

• Long-range planning & Impact analysis

• Serialized data share and systems interoperability

• Revising strategy in response to legislation

• Trading partner connection (CMO and CPO to Client)

Today Regulator Perception vs. CMO/CPO Reality

Global Regulations

Perception - Simple

Customer

Order

CMO/CPO

Make/Package

Customer

Receive/Ship

Wholesaler RX

Reality

CMO

CPO

Mfr A Mfr

B

Mfr C

Mfr D

Mfr E

Mfr F

Mfr G

Mnf H

Mfr I

Mfr J

Mfr K

State of the (Pharma) Industry

Serialization Stage*

EvaluatingStrategy/Providers

Small Pilot

Multi Site Roll Out

Not Started

*IQPC “Pharmaceutical Serialisation and Traceability Survey”, 2012

CMO/CPO Challenges

CMO/CPO Challenges

Regulatory timelines

Regulatory uncertainty

Conflicting demands

Lack of visibility

beyond own walls

Evolving standards

Serialization solutions are

system specific

Meeting multiple

customer requirements

Moving Forward “A project well planned is a project already half done well.”

Tackling the Challenges Be proactive

Develop strategy and a LRP

Identify ROI and Business Value, in advance

Define a core solution

Conduct a Gap Analysis

5 Point Solution A core system that is;

Flexible and scaleable

Standards based

Integration compatible with multiple enterprise

Validation compatibility

Leverages existing infrastructure

Why a 5 Point Solution? Business Value;

First mover advantage- let clients connect to you

Scale with company and client growth

Standardization adjusts to new customer and regulatory

mandates

Not if, but when

Reduce integration costs

Next Steps…

• Conduct a Gap Analysis

• Map all relevant processes

• Identify all work areas effected

• Discover efficiencies from automation

• Gather business requirements

• From customers (their needs and requirements)

• Internally

• Conduct an independent vendor assessment

How can PharmTech help?

Michael Stewart

mstewart@pharmtechinc.com

(847) 281-8924 Office

(815) 403-8425 Cell