SMART PLANT Workflow for Business Process Automation in a Regulated Environment

Transcription

1 SMART PLANT Workflow for Business Process Automation in a Regulated Environment Mary Grow, VP ET & Business Processes, JHP Pharmaceuticals Ty Chasey MES Consultant, Gray Matter Systems August 2011 Put-In-Bay, Ohio

2 JHP Company Overview Corporate Structure Partnership Peter Jenkins & Stuart Hinchen Majority investor: Morgan Stanley Location: Rochester, MI & Parsippany, NJ Employees: approx 350 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 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

3 The injectible drug production process hybrid data intensive costly regulated

4 Process Automation Why the focus now in the pharmaceutical industry A current performance indicator... Pharmaceutical Semiconductor Sigma (σ) ppm Defect Yield 2 308, % 3 66, % 4 6, % % % Conventional Pharmaceutical Manufacturing. production: batch processing quality assurance: laboratory testing of collected samples process change management: via regulatory submissions.vs the Innovation challenge. Significant opportunities exist for improving pharmaceutical development, manufacturing, and quality assurance through innovation in product and process development, process analysis, and process control.

5 Process Automation Why the focus now at JHP 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

6 but with a set of common goals Product Quality Efficiency Innovation Availability Stability Cost

7 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

8 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.

9 Sterile Fill Mission Control

10 Sterile Fill Mission Control

11 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.

12 Sterile Fill Mission Control

13 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

14 Production vs Environment

15 Production Run Start-Up issues 2.5 hours late

16 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

17 Sterile Fill Mission Control and Workflow Integration

18 Workflow Start Batch

19 Workflow End Batch

20 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

21 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.

22 Q&A Mary Grow VP, ET & Business Processes Ty Chasey