Mary Grow, VP ET & Business Processes, JHP Pharmaceuticals Ty Chasey MES Consultant, Gray Matter Systems

17 – 19 August 2011

Put-In-Bay, Ohio

SMART PLANT

Workflow for Business Process Automation in a Regulated Environment

• Industry & Markets

• Commercial pharmaceutical: no innovator R&D or clinical trials • Key products: Injectables in vials and ampoules • Key production technology: lyophilization • branded products: primarily USA with some export to resellers • contract manufacture: primarily USA; certified to export to 86 countries

JHP Company Overview

• Competitors • Other generic injectable manufacturers/marketers (Hospira) • Other injectable contract manufacturers (HollisterStier, DSM, BVL) • “Big pharma” (Pfizer, Sanofi, etc)

• Business Strategy Overview • Focus strengths on generic developments • improve market share via cost containment & product differentiation • maintain current regulatory position but continue to improve • preserve EBITDA • self-finance where possible • retain control of customer-touch activities

• Corporate Structure • Partnership – Peter Jenkins & Stuart Hinchen • Majority investor: Morgan Stanley • Location: Rochester, MI & Parsippany, NJ • Employees: approx 350

The injectible drug production process

hybrid

“data intensive”

costly

regulated

A current performance indicator......

Pharmaceutical

Semiconductor

Sigma (σ) ppm Defect Yield 2 308,537 69.15% 3 66,807 93.32% 4 6,210 99.38% 5 233 99.98% 6 3.4 99.99966%

Process Automation – Why the focus now in the pharmaceutical industry

Conventional Pharmaceutical

Manufacturing….

• production: batch processing • quality assurance: laboratory testing of collected samples • process change management: via regulatory submissions “ Significant opportunities exist for improving pharmaceutical development, manufacturing, and quality assurance through innovation in product and process development, process analysis, and process control.”

….vs the Innovation

challenge….

Compliance regulators pushing records digitization, process understanding, predictive analytics Customer Service customers demanding newer technologies including serialization and track & trace Corporate growth profitably now means significant productivity gains in operations Cash flow / Cost containment “cost per vial” metric even more important as company moves to generics

Process Automation Why the focus now at JHP

…but with a set of common goals…

Product Quality

Efficiency

Innovation Availability

Stability

Cost

Process Automation – How we got started....

Operations: operational effectiveness understanding business processes paper reduction Facilities focus: equipment upgrades / replacement process understanding quality control ET focus technical operations support new technology deployment

Introduction to the Solution What we’ve done to date…………

Project 1: Workflow to make plant apps more inclusive and effective What we did: Combined iFix, Historian, Workflow, and Plant Applications to collect contextualized Batch data.

Sterile Fill Mission Control

Sterile Fill Mission Control

Sterile Fill Mission Control

• Both Plant Applications and Workflow seamlessly integrate into the iFix environment.

• Plant Applications adds context to downtime events.

• Workflows - paperless batch reconciliation.

Sterile Fill Mission Control

Plant Applications Web Reports • Entire operation has access

to OEE, Downtime, Environmental Trends, and Production Reports.

• Some report highlights include: – Production vs. environmental

data – Start-up issues

Production vs Environment

Production Run Start-Up issues

2.5 hours late

Introduction to the Solution What we’ve done to date…………

Project 2. Workflow to support our paper reduction efforts….. …..and lay the foundation for electronic batch record

What we did: replaced paper forms with screens for data input for batch reconciliation

Sterile Fill Mission Control and Workflow Integration

Workflow – Start Batch

Workflow – End Batch

Process Automation Example 3: electronic batch record

What we’re doing now: Finalizing the spec for an electronic batch record

– Environmental Data – PAT / Process Improvement – Following the FDA approved validation

process and filling out required forms. – Data is stored in S95 Production Model

The Challenge for JHP… Any change impacting product must be approved by outside agencies.

We have to change the engine without pitting the car.

We are implementing in a somewhat “hostile” physical environment.

We have to convince our employees that this is not going to replace them.

Q&A

• Mary Grow – VP, ET & Business Processes – mary.grow@jhppharma.com

• Ty Chasey